Status:
RECRUITING
A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
Lead Sponsor:
Glaukos Corporation
Conditions:
Persistent Corneal Epithelial Defect
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief 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 ev...
Detailed Description
This study is a randomized, multicenter, double-masked, vehicle-controlled study to evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epitheli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05966493
Start Date
August 17 2023
End Date
December 1 2025
Last Update
July 24 2025
Active Locations (28)
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1
Glaukos Investigative Site
Dothan, Alabama, United States, 36301
2
Glaukos Investigative Site
Petaluma, California, United States, 94954
3
Glaukos Investigative Site
Torrance, California, United States, 90505
4
Glaukos Investigative Site
Colorado Springs, Colorado, United States, 80924