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A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
Sponsor: Glaukos Corporation
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
Conditions
Interventions
lufepirsen high dose
Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
Vehicle
Matching vehicle without lufepirsen.
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