A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With Persistent Corneal Epithelial Defects (NEXPEDE-1)
Glaukos Corporation
84 participants
Aug 17, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria10
- 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.
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Interventions
Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
Matching vehicle without lufepirsen.
Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
Locations(28)
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NCT05966493