Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy

Conditions

• Fuchs Endothelial Corneal Dystrophy

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• N-acetyl cysteine (NAC) 10% solution — DRUG
  N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.
• N-acetyl cysteine (NAC) 20% solution — DRUG
  N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.
• Visine Dry Eye Relief eye drops — DRUG
  Visine Tears Dry Eye Relief artificial tears ophthalmic solution

Study Details

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

Key Dates

Start date

Sep 16, 2020

Status verified

Sep 2025

Primary completion

Apr 29, 2026

Completion

Apr 30, 2027

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.)

Primary Outcome Measure

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

Central Contacts

• Michael Cheung, MSc, CCRP
  6175736060
  [email protected]
• Ula Jurkunas, MD
  617-573-4330
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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