NCT05966493

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Persistent Corneal Epithelial Defect

Interventions

Type	Name	Description
DRUG	lufepirsen high dose	Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
DRUG	Vehicle	Matching vehicle without lufepirsen.
DRUG	lufepirsen low dose	Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-07-28
• Last updated: 2025-07-24

Locations

28 sites across 4 countries: United States, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study