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Clinical Trials in Germany / NCT05966493
Recruiting Phase 2

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

NCT05966493 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2023-08-17
Last updated
2025-07-24

Condition(s) studied

Persistent Corneal Epithelial Defect

Investigational drug(s) / intervention(s)

lufepirsen high doseVehiclelufepirsen low dose

lufepirsen high dose: Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Vehicle: Matching vehicle without lufepirsen.

lufepirsen low dose: Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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 2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment 3. Subject must provide written informed consent (or assent) 4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test Exclusion Criteria: 1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention 2. 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 3. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye 4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active 5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time 6. Have any other ocular disease requiring topical ocular medication in the affected eye 7. 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 8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein) 9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1 10. Use of the medications presented in the protocol that are prohibited in the study.

Primary outcome measure(s)

Trial sites (28)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05966493 on ClinicalTrials.gov ↗ ← All trials in Germany