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NCT04440280 · ClinicalTrials.gov registry record · Phase 2
Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
A Phase 2 study of Fuchs Endothelial Corneal Dystrophy, sponsored by Massachusetts Eye and Ear Infirmary.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04440280: Recruiting Phase 2 study of Fuchs Endothelial Corneal Dystrophy, sponsored by Massachusetts Eye and Ear Infirmary.
NCT04440280 is a Phase 2 study of Fuchs Endothelial Corneal Dystrophy that is actively recruiting participants, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 45 participants, below the 52-participant average among 3 other Fuchs Endothelial Corneal Dystrophy trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04440280, a Phase 2 study of Fuchs Endothelial Corneal Dystrophy, is actively recruiting participants, sponsored by Massachusetts Eye and Ear Infirmary.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary endpoint is the level of H2O2 in the aqueous humor obtained at time of DMEK surgery.
Conditions Studied
Interventions
- DRUG N-acetyl cysteine (NAC) 10% solution
- DRUG N-acetyl cysteine (NAC) 20% solution
- DRUG Visine Dry Eye Relief eye drops
Study Locations (1)
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
What NCT04440280 shows while recruiting
NCT04440280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 52-participant average among 3 other Fuchs Endothelial Corneal Dystrophy trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Fuchs Endothelial Corneal Dystrophy appearing as the primary indexed condition, and to 3 interventions - of which N-acetyl cysteine (NAC) 10% solution is the first listed.
NCT04440280 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04440280 about?
NCT04440280 is a clinical study titled "Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy". 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 is the current status of trial NCT04440280?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2020-09-16. Estimated completion is 2027-04-30.
What conditions does trial NCT04440280 study?
This clinical trial studies the following conditions: Fuchs Endothelial Corneal Dystrophy.
What interventions are being tested in trial NCT04440280?
The interventions under investigation include: N-acetyl cysteine (NAC) 10% solution (DRUG), N-acetyl cysteine (NAC) 20% solution (DRUG), Visine Dry Eye Relief eye drops (DRUG).
Who is sponsoring clinical trial NCT04440280?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04440280 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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