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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Persistent Corneal Epithelial Defect

In brief

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.

Key facts

Study ID

NCT05966493

Run by

Glaukos Corporation

People needed

84

Starts

2023-08-17

Expected to finish

2025-12-01

Last updated by the study team

2025-07-24

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Glaukos Investigative Site — Dothan, Alabama, United States (enrolling)
• Glaukos Investigative Site — Petaluma, California, United States (enrolling)
• Glaukos Investigative Site — Torrance, California, United States (enrolling)
• Glaukos Investigative Site — Colorado Springs, Colorado, United States (enrolling)
• Glaukos Investigative Site — Grand Junction, Colorado, United States (enrolling)
• Glaukos Investigative Site — Bradenton, Florida, United States (enrolling)
• Glaukos Investigative Site — Fort Myers, Florida, United States (enrolling)
• Glaukos Investigative Site — South Miami, Florida, United States (enrolling)
• Glaukos Investigative Site — Atlanta, Georgia, United States (enrolling)
• Glaukos Investigative Site — Carmel, Indiana, United States (enrolling)
• Glaukos Investigative Site — Fraser, Michigan, United States (enrolling)
• Glaukos Investigative Site — Kansas City, Missouri, United States (enrolling)
• Glaukos Investigative Site — Kansas City, Missouri, United States (enrolling)
• Glaukos Investigative Site — Palisades Park, New Jersey, United States (enrolling)
• Glaukos Investigative Site — Shelby, North Carolina, United States (enrolling)
• Glaukos Investigative Site — Bala-Cynwyd, Pennsylvania, United States (enrolling)
• Glaukos Investigative Site — Nashville, Tennessee, United States (enrolling)
• Glaukos Investigative Site — Houston, Texas, United States (enrolling)
• Glaukos Investigative Site — San Antonio, Texas, United States (enrolling)
• Glaukos Investigative Site — Madison, Wisconsin, United States (enrolling)
• Glaukos Investigative Site — Milwaukee, Wisconsin, United States (enrolling)
• Glaukos Investigative Site — Mainz, Germany (enrolling)
• Glaukos Investigative Site — München, Germany (enrolling)
• Glaukos investigative Site — Messina, Italy (enrolling)
• Glaukos Investigative Site — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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