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NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries

NCT04081103 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-07-14

Study results available
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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.

Conditions

  • Corneal Persistent Epithelial Defect

Interventions

DRUG

Nexagon® (lufepirsen) High Dose Concentration

Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.

DRUG

Nexagon® (lufepirsen) Low Dose Concentration

Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.

DRUG

Vehicle

Vehicle is administered topically in the affected eye three (3) times over 28 days.

DRUG

Open-label Nexagon® (lufepirsen)

Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.

Sponsors & Collaborators

  • Amber Ophthalmics, Inc.

    collaborator INDUSTRY

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Maria Feldman · Amber Ophthalmics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2022-02-07
Completion
2022-02-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081103 on ClinicalTrials.gov