A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED — NEXPEDE-1  

Persistent Corneal Epithelial Defect Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study is a randomized, multicenter, double-masked, vehicle-controlled study to evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED). The study will enroll subjects who will complete a Screening Period, Treatment Period (up to 8 weeks) and Follow-up Period (4 weeks). Those subjects whose defect has not re-epithelialized by the completion of the Treatment Period or who achieved re-epithelialization but failed to maintain re-epithelialization for 28 days after treatment completion (durability) are eligible to enter the NEXAGON Open-label Treatment Period for an additional 8 weeks. ;

Related Conditions & MeSH terms

• Persistent Corneal Epithelial Defect

• NCT number: NCT05966493
• Study type: Interventional
• Source: Amber Ophthalmics, Inc.
• Contact: President and CSO, PharmD
• Phone: 858-663-1500
• Email: clinical@amberophthalmics.com
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2023
• Completion date: October 2024