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

RecruitingPhase 2Ages 2 Years - anyAllGlaukos Corporation
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • lufepirsen high dose
  • Vehicle
  • lufepirsen low dose
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Where

28 sites
Glaukos Investigative Site
Dothan, United States
Glaukos Investigative Site
Petaluma, United States
Glaukos Investigative Site
Torrance, United States
Glaukos Investigative Site
Colorado Springs, United States
Glaukos Investigative Site
Grand Junction, United States
Glaukos Investigative Site
Bradenton, United States
Glaukos Investigative Site
Fort Myers, United States
Glaukos Investigative Site
South Miami, United States

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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