RecruitingPhase 2NCT05966493

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)

Sponsor

Glaukos Corporation

Enrollment

84 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

Conditions

Persistent Corneal Epithelial Defect

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.

Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vehicle, a drug called lufepirsen high dose, and others for people with persistent corneal epithelial defect. The study is currently recruiting participants at 28 locations. People eligible for this study include aged 2 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGlufepirsen high dose

Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

DRUGVehicle

Matching vehicle without lufepirsen.

DRUGlufepirsen 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

View Full Details on ClinicalTrials.gov

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NCT05966493

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