← Back to Search

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

Study Summary

This trial will test whether N-acetyl cysteine eye drops can protect patients with FECD from oxidative stress.

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.Check my eligibility
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.See study design
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
Select...
I need surgery for a cornea transplant and cataract removal at the same time.
Select...
I am 21 years old or older.
Select...
I have advanced Fuchs' dystrophy and a significant cataract affecting my vision.
Select...
I am willing and able to follow the medication plan.
Select...
I am willing and able to follow the medication plan.
Select...
I am 21 years old or older.

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and tolerability will be assessed after participants have taken study drug for 28 days or earlier, if the participants report difficulties tolerating the drug. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of H2O2 in the aqueous humor
Secondary outcome measures
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

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.)

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,904 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

N-acetyl cysteine (NAC) 10% solution (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT04440280 — Phase 2
Fuchs' Dystrophy Research Study Groups: NAC 20% group, Placebo group, NAC 10% group
Fuchs' Dystrophy Clinical Trial 2023: N-acetyl cysteine (NAC) 10% solution Highlights & Side Effects. Trial Name: NCT04440280 — Phase 2
N-acetyl cysteine (NAC) 10% solution (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04440280 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research recruiting participants at present?

"As per the clinicaltrials.gov website, this trial is actively recruiting participants and has been since it was first posted on September 16th 2020 with its most recent update being October 5th 2021."

Answered by AI

Has the regulatory body approved NAC 10% group for public use?

"NAC 10% has been awarded a safety index score of 2 due to the fact that there is only preliminary evidence indicating its security, but no data evaluating it's efficacy."

Answered by AI

To what conditions is NAC 10% typically prescribed?

"NAC 10% group is a recommended treatment for parenteral nutrition, total amino acid supplementation therapy, and dry eyes."

Answered by AI

Have any prior experiments been conducted using the NAC 10% cohort?

"At the time of this writing, 28 clinical trials are actively studying NAC 10% group with 7 being in Phase 3. Of these studies, a significant number are running out of Halifax, Nova Scotia but there is also support for participants at 55 other locations across the globe."

Answered by AI

What is the cap on enrollment for this medical experiment?

"Affirmative. Per the clinicaltrials.gov listing, this trial is currently open for recruitment and was initially published on September 16th 2020. The last revision to the listing occurred October 5th 2021 and 45 patients need to be recruited from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby May 2024