A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
Start Date
8/17/2023
Completion Date
12/1/2025
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.
Eligibility Criteria
Age Range: 2 years to No maximum
Interventions
lufepirsen high dose
Vehicle
lufepirsen low dose
Conditions
Locations
Glaukos Investigative Site
Dothan, Alabama 36301
United States
Glaukos Investigative Site
Petaluma, California 94954
United States
Glaukos Investigative Site
Torrance, California 90505
United States
Glaukos Investigative Site
Colorado Springs, Colorado 80924
United States
Glaukos Investigative Site
Grand Junction, Colorado 81501
United States
Glaukos Investigative Site
Bradenton, Florida 34209
United States
Glaukos Investigative Site
Fort Myers, Florida 33907
United States
Glaukos Investigative Site
South Miami, Florida 33143
United States
Glaukos Investigative Site
Atlanta, Georgia 30339
United States
Glaukos Investigative Site
Carmel, Indiana 46032
United States
Glaukos Investigative Site
Fraser, Michigan 48026
United States
Glaukos Investigative Site
Kansas City, Missouri 64133
United States
Glaukos Investigative Site
Kansas City, Missouri 64154
United States
Glaukos Investigative Site
Palisades Park, New Jersey 07650
United States
Glaukos Investigative Site
Shelby, North Carolina 28150
United States
Glaukos Investigative Site
Bala-Cynwyd, Pennsylvania 19004
United States
Glaukos Investigative Site
Nashville, Tennessee 37215
United States
Glaukos Investigative Site
Houston, Texas 77025
United States
Glaukos Investigative Site
San Antonio, Texas 78209
United States
Glaukos Investigative Site
Madison, Wisconsin 53705
United States
Glaukos Investigative Site
Milwaukee, Wisconsin 53226
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