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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 is a Phase 2 study that was terminated before completion, run by Glaukos Corporation. The registered enrollment target is 35 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04081103
The ClinicalTrials.gov registry entry for NCT04081103 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glaukos Corporation, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Vehicle is the first listed.
NCT04081103 reports 0 study locations.
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.
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