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

Launched by GLAUKOS CORPORATION · Jul 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called NEXAGON® (lufepirsen ophthalmic gel) for people with Persistent Corneal Epithelial Defect (PCED). PCED is a condition where the surface of the eye does not heal properly, which can cause discomfort and vision problems. The main goal of this study is to see if NEXAGON is safe to use and if it helps improve this condition in patients who have not responded well to standard treatments.

To participate in the trial, you should have had PCED for at least two weeks and not seen any improvement despite using other treatments. You will need to give your consent to join, and if you are a woman who can become pregnant, you must meet specific criteria regarding pregnancy. The study is currently recruiting participants of all genders and from ages 730 and above. If you join, you will be monitored closely to assess how well the treatment works and to ensure your safety. This trial represents an important step in finding better treatments for those suffering from PCED.

Gender

ALL

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.