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RecruitingPhase 2

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

Glaukos Corporation · NCT05966493

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
84
US sites recruiting
21
Study start
August 17, 2023
Record last updated
July 24, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: lufepirsen high dose; Vehicle; lufepirsen low dose

Conditions: Persistent Corneal Epithelial Defect

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
  • Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
  • Subject must provide written informed consent (or assent)
  • Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

Exclusion Criteria

  • Have a known ocular infection that is deemed to be active requiring therapeutic intervention
  • Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed
  • Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
  • Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
  • Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
  • Have any other ocular disease requiring topical ocular medication in the affected eye
  • Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results
  • Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
  • Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
  • Use of the medications presented in the protocol that are prohibited in the study.

Recruiting US locations

  • Glaukos Investigative Site

    Dothan, AL 36301

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Petaluma, CA 94954

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Torrance, CA 90505

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Colorado Springs, CO 80924

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Grand Junction, CO 81501

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Bradenton, FL 34209

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Fort Myers, FL 33907

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    South Miami, FL 33143

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Atlanta, GA 30339

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Carmel, IN 46032

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Fraser, MI 48026

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Kansas City, MO 64133

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Kansas City, MO 64154

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Palisades Park, NJ 07650

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Shelby, NC 28150

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Bala-Cynwyd, PA 19004

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Nashville, TN 37215

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Houston, TX 77025

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    San Antonio, TX 78209

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Madison, WI 53705

    Site contact: Study Coordinator · 949-739-8749

  • Glaukos Investigative Site

    Milwaukee, WI 53226

    Site contact: Study Coordinator · 949-739-8749

Study contacts (from the official record)

  • Study Director · 949-739-8749 · ClinicalResearch@Glaukos.com
A Study to Evaluate the Safety and Efficacy of NEXAGON®… (NCT05966493) | Bored Studies