A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1)
- Sponsor: Glaukos Corporation
- Principal Investigator: Evan Warner, MD
- Study Coordinator: Chris Smith
Study Objective
To evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED).
Study Design
Randomized subjects in this study will receive topical ocular dose administrations of the investigational product (NEXAGON 0.06 % or vehicle) in the clinic on Days 1, 2, 8, 15, and 22. Subjects not achieving corneal re-epithelialization on Day 29 will go on to receive weekly dose administrations of IP (Days 29, 36, 43, and 50) until corneal re-epithelialization is achieved, or the subject reaches Day 57 without re-epithelializing.
Inclusion Criteria:
- 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.
- PCED measuring at least 1 mm along the largest diameter.
- Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test.
Exclusion Criteria:
- 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 in the opinion of the Investigator 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.
Contact Chris Smith with questions at (608) 263-7169
For more information about this study, visit clinicaltrials.gov.