Back to Trials
NCT05966493PHASE2Recruiting

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

Glaukos Corporation

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

Inclusion Criteria: 1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments 2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment 3. Subject must provide written informed consent (or assent) 4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test Exclusion Criteria: 1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention 2. Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed 3. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye 4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active 5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time 6. Have any other ocular disease requiring topical ocular medication in the affected eye 7. Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results 8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein) 9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1 10. Use of the medications presented in the protocol that are prohibited in the study.

Interventions

DRUG

lufepirsen high dose

DRUG

Vehicle

DRUG

lufepirsen low dose

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Persistent Corneal Epithelial Defect

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