NCT04081103

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

A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) in Subjects With Corneal Persistent Epithelial Defects

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-06-30
• Primary completion: 2022-02-07
• Completion: 2022-02-07
• First posted: 2019-09-09
• Last updated: 2025-07-14
• Results posted: 2024-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study