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RECRUITING
NCT05966493
PHASE2

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

Sponsor: Glaukos Corporation

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2023-08-17

Completion Date

2025-12

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

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.

Locations (28)

Glaukos Investigative Site

Dothan, Alabama, United States

Glaukos Investigative Site

Petaluma, California, United States

Glaukos Investigative Site

Torrance, California, United States

Glaukos Investigative Site

Colorado Springs, Colorado, United States

Glaukos Investigative Site

Grand Junction, Colorado, United States

Glaukos Investigative Site

Bradenton, Florida, United States

Glaukos Investigative Site

Fort Myers, Florida, United States

Glaukos Investigative Site

South Miami, Florida, United States

Glaukos Investigative Site

Atlanta, Georgia, United States

Glaukos Investigative Site

Carmel, Indiana, United States

Glaukos Investigative Site

Fraser, Michigan, United States

Glaukos Investigative Site

Kansas City, Missouri, United States

Glaukos Investigative Site

Kansas City, Missouri, United States

Glaukos Investigative Site

Palisades Park, New Jersey, United States

Glaukos Investigative Site

Shelby, North Carolina, United States

Glaukos Investigative Site

Bala-Cynwyd, Pennsylvania, United States

Glaukos Investigative Site

Nashville, Tennessee, United States

Glaukos Investigative Site

Houston, Texas, United States

Glaukos Investigative Site

San Antonio, Texas, United States

Glaukos Investigative Site

Madison, Wisconsin, United States

Glaukos Investigative Site

Milwaukee, Wisconsin, United States

Glaukos Investigative Site

Mainz, Germany

Glaukos Investigative Site

München, Germany

Glaukos investigative Site

Messina, Italy

Glaukos Investigative Site

Barcelona, Spain

Glaukos Investigative Site

Madrid, Spain

Glaukos Investigative Site

Seville, Spain

Glaukos Investigative Site

Zaragoza, Spain