A clinical trial to evaluate the safety and the efficacy of NEXAGON ® (Lufepirsen Ophthalmic Gel) in subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1)

Phase 1

Conditions: Persistent Corneal Epithelial Defects
MedDRA version: 21.1Level: PTClassification code: 10075399Term: Persistent corneal epithelial defect Class: 100000004863
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: CTIS2023-507030-24-00

Lead Sponsor: Amber Ophthalmics Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

male or female •Who are at least 2 years of age (US only) • Who are at least 18 years of age (all other countries), the presence of a corneal epithelial defect that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments, as assessed by the Investigator, must have no clinical evidence of improvement in corneal epithelial defect within 2 weeks prior to randomization despite the use of non-surgical SOC treatment, as assessed by the Investigator, an epithelial defect measuring at least 2 mm along the largest diameter at Day 1 of the Treatment Period, subjects or their legally authorized representative(s) must have the ability to provide written informed consent, and must do so, prior to participation in any study-related procedures, female subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test at Visit 1 and 2; women of childbearing potential must use an acceptable form of contraception throughout the study. Adequate birth control methods, including but not limited to, abstinence, stabilized on hormonal contraception [i.e., a) oral or patch/transdermal contraceptives for at least one full cycle (e.g., one or two months), or b) implant, injection, vaginal ring (e.g., NuvaRing®) for at least one week, intrauterine device (IUD) for at least one week, condom and a spermicidal, diaphragm and a spermicidal, or sterile solitary partner (vasectomy performed at least six months prior), must have the ability and willingness to comply with all study procedures

Exclusion Criteria

any known ocular infection(s) that are deemed to be active (bacterial, viral, fungal and/or protozoal) requiring therapeutic intervention at the time of randomization in the affected eye(s), 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 table below are prohibited in the study., 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, evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye, blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active (i.e., requiring mechanical lid hygiene = once a week or systemic treatment for blepharitis associated with MGD), history of a full thickness keratoplasty, > 1 Descemet membrane endothelial keratoplasty (DMEK) or Descemet’s stripping endothelial keratoplasty (DSEK) procedure, history of ocular surgery or any ocular procedure(s) not meeting the designated washout time prior to Day 1 of the study, any other ocular disease requiring topical ocular medication in the affected eye during the course of the study treatment period, a Schirmer I test result (without anesthesia) of = 3 mm/5 minutes in the study eye, a presence or history of any ocular or systemic disorder or condition that could interfere with the safety or efficacy of the study treatment, or the interpretation of the study results. Such degenerative and/or progressing ocular or systemic disorders are, but not limited to: lagophthalmos, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, active systemic infection, neoplastic diseases