Recruiting
Phase 2

NEXAGON

Sponsor:

Glaukos Corporation

Code:

NCT05966493

Conditions

Persistent Corneal Epithelial Defect

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

lufepirsen high dose

Vehicle

lufepirsen low dose

Study Details

Brief 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.

Conditions

Persistent Corneal Epithelial Defect

Study ID

NCT05966493

Start date

Aug 17, 2023

Status verified date

Jul, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration

Lufepirsen (High dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.

placebo comparator: NEXAGON Vehicle (ophthalmic gel)

Vehicle applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.

experimental: NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only)

Lufepirsen (Low dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. (EU sites only).

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.

Primary outcome measure

  • Achieve Corneal Re-epithelialization Including Durability (CRC) [ Time Frame: End of Study: 28 Days after achieving re-epithelialization ]

Central Contacts and Locations

Central contacts

Locations

Glaukos Investigative Site

Recruiting

Dothan, Alabama, United States, 36301

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Petaluma, California, United States, 94954

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Torrance, California, United States, 90505

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Colorado Springs, Colorado, United States, 80924

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Grand Junction, Colorado, United States, 81501

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Fort Myers, Florida, United States, 33907

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

South Miami, Florida, United States, 33143

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Atlanta, Georgia, United States, 30339

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Fraser, Michigan, United States, 48026

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Kansas City, Missouri, United States, 64133

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Palisades Park, New Jersey, United States, 07650

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Shelby, North Carolina, United States, 28150

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Nashville, Tennessee, United States, 37215

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Houston, Texas, United States, 77025

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

San Antonio, Texas, United States, 78209

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Study Coordinator

949-739-8749

Glaukos Investigative Site

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Study Coordinator

949-739-8749

More Information

Sponsor

Glaukos Corporation

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • PCED
  • Corneal Defect
  • PED

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2025-07-24.