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A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

Study acronym: NEXPEDE-1
StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated July 24, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Lead sponsor: Amber Ophthalmics, Inc. to Glaukos Corporation
    • Study sites: 1 to 28
    • Interventions: Vehicle (Drug), lufepirsen (Drug) to Vehicle (Drug), lufepirsen high dose (Drug), lufepirsen low dose (Drug)
    • Study arms: 2 to 3
    v3
  3. Phase: Phase 2/3 to Phase 2v2 Show 7 more changesShow less
    • Enrollment target: 120 to 84
    • Primary and study completion dates: Oct 2024 to Dec 2025
    • Study sites: 6 to 1
    • Start date changed from estimate of Jul 2023 to Aug 17, 2023
    • Eligibility criteria shortened, about 83 words
    • Secondary endpoints shortened, about 80 words
    • Study arms: 3 to 2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.
Trial Details
NCT Number NCT05966493
Lead Sponsor Glaukos Corporation
Conditions
(from sponsor)		 Persistent Corneal Epithelial Defect
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov