NCT05966493 A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
| NCT ID | NCT05966493 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Glaukos Corporation |
| Condition | Persistent Corneal Epithelial Defect |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2023-08-17 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 evaluate the safety and efficacy of NEXAGON in this population.
Eligibility Criteria
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.
Contact & Investigator
Luis G. Vargas, MD
STUDY DIRECTOR
Glaukos Corporation
Frequently Asked Questions
Who can join the NCT05966493 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Persistent Corneal Epithelial Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05966493 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05966493 currently recruiting?
Yes, NCT05966493 is actively recruiting participants. Contact the research team at ClinicalResearch@Glaukos.com for enrollment information.
Where is the NCT05966493 trial being conducted?
This trial is being conducted at Dothan, United States, Petaluma, United States, Torrance, United States, Colorado Springs, United States and 11 additional locations.
Who is sponsoring the NCT05966493 clinical trial?
NCT05966493 is sponsored by Glaukos Corporation. The principal investigator is Luis G. Vargas, MD at Glaukos Corporation. The trial plans to enroll 84 participants.