NCT05966493

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2023

Geographic Reach
4 countries

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

August 17, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

June 20, 2023

Last Update Submit

July 21, 2025

Conditions

Persistent Corneal Epithelial Defect

Keywords

PCEDCorneal DefectPED

Outcome Measures

Primary Outcomes (1)

  • Achieve Corneal Re-epithelialization Including Durability (CRC)

    The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).

    End of Study: 28 Days after achieving re-epithelialization

Study Arms (3)

NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration

EXPERIMENTAL

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

Drug: lufepirsen high dose

NEXAGON Vehicle (ophthalmic gel)

PLACEBO COMPARATOR

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

Drug: Vehicle

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

EXPERIMENTAL

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).

Drug: lufepirsen low dose

Interventions

lufepirsen high doseDRUG

Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Also known as: NEXAGON®
NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration
VehicleDRUG

Matching vehicle without lufepirsen.

Also known as: Placebo
NEXAGON Vehicle (ophthalmic gel)
lufepirsen low doseDRUG

Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Also known as: NEXAGON®
NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only)

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
  • Subject must provide written informed consent (or assent)
  • Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

You may not qualify if:

  • Have a known ocular infection that is deemed to be active requiring therapeutic intervention
  • 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
  • Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
  • Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
  • Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
  • Have any other ocular disease requiring topical ocular medication in the affected eye
  • 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
  • Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
  • Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
  • Use of the medications presented in the protocol that are prohibited in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Glaukos Investigative Site

Dothan, Alabama, 36301, United States

RECRUITING

Glaukos Investigative Site

Petaluma, California, 94954, United States

RECRUITING

Glaukos Investigative Site

Torrance, California, 90505, United States

RECRUITING

Glaukos Investigative Site

Colorado Springs, Colorado, 80924, United States

RECRUITING

Glaukos Investigative Site

Grand Junction, Colorado, 81501, United States

RECRUITING

Glaukos Investigative Site

Bradenton, Florida, 34209, United States

RECRUITING

Glaukos Investigative Site

Fort Myers, Florida, 33907, United States

RECRUITING

Glaukos Investigative Site

South Miami, Florida, 33143, United States

RECRUITING

Glaukos Investigative Site

Atlanta, Georgia, 30339, United States

RECRUITING

Glaukos Investigative Site

Carmel, Indiana, 46032, United States

RECRUITING

Glaukos Investigative Site

Fraser, Michigan, 48026, United States

RECRUITING

Glaukos Investigative Site

Kansas City, Missouri, 64133, United States

RECRUITING

Glaukos Investigative Site

Kansas City, Missouri, 64154, United States

RECRUITING

Glaukos Investigative Site

Palisades Park, New Jersey, 07650, United States

RECRUITING

Glaukos Investigative Site

Shelby, North Carolina, 28150, United States

RECRUITING

Glaukos Investigative Site

Bala-Cynwyd, Pennsylvania, 19004, United States

RECRUITING

Glaukos Investigative Site

Nashville, Tennessee, 37215, United States

RECRUITING

Glaukos Investigative Site

Houston, Texas, 77025, United States

RECRUITING

Glaukos Investigative Site

San Antonio, Texas, 78209, United States

RECRUITING

Glaukos Investigative Site

Madison, Wisconsin, 53705, United States

RECRUITING

Glaukos Investigative Site

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Glaukos Investigative Site

Mainz, Germany

RECRUITING

Glaukos Investigative Site

München, Germany

RECRUITING

Glaukos investigative Site

Messina, Italy

RECRUITING

Glaukos Investigative Site

Barcelona, Spain

RECRUITING

Glaukos Investigative Site

Madrid, Spain

RECRUITING

Glaukos Investigative Site

Seville, Spain

RECRUITING

Glaukos Investigative Site

Zaragoza, Spain

RECRUITING

Study Officials

  • Luis G. Vargas, MD

    Glaukos Corporation

    STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

949-739-8749ClinicalResearch@Glaukos.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 28, 2023

Study Start

August 17, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(21)DE(2)IT(1)ES(4)