What this study is
This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.
What's being tested
- N-acetyl cysteine (NAC) 10% solution
Intervention · DRUG
N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.
- N-acetyl cysteine (NAC) 20% solution
Intervention · DRUG
N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.
- Visine Dry Eye Relief eye drops
Intervention · DRUG
Visine Tears Dry Eye Relief artificial tears ophthalmic solution
Study details
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Enrolling
- 45 people
- Starts
- 2020-09-16
- Est. completion
- 2027-04-30
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or female ≥21 years of age at time of surgical evaluation.
- Diagnosis of advanced FECD and visually significant cataract
- Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Willingness and ability to adhere to medication regimen
You can't join if
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- History of prior intraocular surgery in study eye including cataract, glaucoma and/or retina surgery
- 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
- History of ocular surface infection within the past 30 days
- Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days
- History of intolerance to topical N-Acetylcysteine
- 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. -
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMassachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
- Ula Jurkunas, MD · Contact6175734330Ula_Jurkunas@meei.harvard.edu
- Michael Cheung, MSc. CCRP · Contact6175736060 ext. Cheungmcheung0@meei.harvard.edu
- Ula Jurkunas, MD · Principal investigator
Recruiting
Study team
Sponsor
Massachusetts Eye and Ear Infirmary
Study ID 2020P001909
Principal investigator
Ula Jurkunas, MD
Mass Eye and Ear
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.