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NCT04081103 · ClinicalTrials.gov registry record · Phase 2
NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries
A Phase 2 study, sponsored by Glaukos Corporation.
- Terminated
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT04081103: Clinical Trial Phase 2 study, sponsored by Glaukos Corporation.
NCT04081103 is a Phase 2 study that was terminated before completion, run by Glaukos Corporation. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04081103, a Phase 2 study, was terminated before completion, sponsored by Glaukos Corporation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.
Primary Outcome
Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination.
Interventions
- DRUG Vehicle
- DRUG Nexagon® (lufepirsen) High Dose Concentration
- DRUG Nexagon® (lufepirsen) Low Dose Concentration
- DRUG Open-label Nexagon® (lufepirsen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2022-02-07 |
| Phase | Phase 2 |
Why NCT04081103 stopped before completion
NCT04081103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which Vehicle is the first listed.
NCT04081103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04081103 about?
NCT04081103 is a clinical study titled "NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries". This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon...
What is the current status of trial NCT04081103?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2020-06-30. Estimated completion is 2022-02-07.
What interventions are being tested in trial NCT04081103?
The interventions under investigation include: Vehicle (DRUG), Nexagon® (lufepirsen) High Dose Concentration (DRUG), Nexagon® (lufepirsen) Low Dose Concentration (DRUG), Open-label Nexagon® (lufepirsen) (DRUG).
Who is sponsoring clinical trial NCT04081103?
This trial is sponsored by Glaukos Corporation, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04081103's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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