Recruiting
Phase 2

Reactive Oxygen Species

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT04440280

Conditions

Fuchs Endothelial Corneal Dystrophy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

N-acetyl cysteine (NAC) 10% solution

N-acetyl cysteine (NAC) 20% solution

Visine Dry Eye Relief eye drops

Study Details

Brief summary:

This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.

Conditions

Fuchs Endothelial Corneal Dystrophy

Study ID

NCT04440280

Start date

Sep 16, 2020

Status verified date

Sep, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female ≥21 years of age at time of surgical evaluation.
2. Diagnosis of advanced FECD and visually significant cataract
3. Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery
4. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
5. Willingness and ability to adhere to medication regimen

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
2. History of prior intraocular surgery in study eye including cataract, glaucoma and/or retina surgery
3. History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic bullous keratopathy, corneal degenerations, corneal infections
4. Use of ocular prescription medications except for lubricants, hyperosmotic agents, or ocular hypotensive agents
5. History of ocular surface infection within the past 30 days
6. Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days
7. History of intolerance to topical N-Acetylcysteine
8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

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Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NAC 10% group

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.

active comparator: NAC 20% group

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.

placebo comparator: Placebo group

Subjects in this group will be treated with a placebo (Visine Tears Dry Eye Relief artificial tears ophthalmic solution.)

Interventions

N-acetyl cysteine (NAC) 10% solution

N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.

N-acetyl cysteine (NAC) 20% solution

N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.

Visine Dry Eye Relief eye drops

Visine Tears Dry Eye Relief artificial tears ophthalmic solution

Primary outcome measure

  • Level of H2O2 in the aqueous humor [ Time Frame: DMEK Surgery occurs 28 to 42 days after participant enrollment ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts Eye and Ear Infirmary

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Ula Jurkunas, MD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Sep 2, 2026

Last verified

Sep, 2025

Keywords

  • Fuchs
  • Fuchs Endothelial Corneal Dystrophy
  • oxidative stress
  • N-Acetylcysteine ophthalmic drops
  • Descemet Membrane Endothelial Keratoplasty
  • DMEK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-09-02.