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Persistent Corneal Epithelial DefectPhase 2NEXPEDE-1NCT05966493

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

A Phase 2 study testing lufepirsen high dose and lufepirsen low dose in people with Persistent Corneal Epithelial Defect, run by Glaukos Corporation at 28 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Persistent Corneal Epithelial Defect
What is being tested?
lufepirsen high dose and lufepirsen low dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
28 sitesin 4 countries
Study dates
17 Aug 2023to Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

28 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

949-739-8749

ClinicalResearch@Glaukos.com

28 sites in 4 countries

United States21 sites, 21 recruiting

  • Glaukos Investigative Site

    Atlanta, Georgia, 30339

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Bala-Cynwyd, Pennsylvania, 19004

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Bradenton, Florida, 34209

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Carmel, Indiana, 46032

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Colorado Springs, Colorado, 80924

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Dothan, Alabama, 36301

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Fort Myers, Florida, 33907

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Fraser, Michigan, 48026

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Grand Junction, Colorado, 81501

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Houston, Texas, 77025

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Kansas City, Missouri, 64133

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Kansas City, Missouri, 64154

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Madison, Wisconsin, 53705

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Milwaukee, Wisconsin, 53226

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Nashville, Tennessee, 37215

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Palisades Park, New Jersey, 07650

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Petaluma, California, 94954

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    San Antonio, Texas, 78209

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Shelby, North Carolina, 28150

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    South Miami, Florida, 33143

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Torrance, California, 90505

    Study Coordinator, 949-739-8749

    Recruiting

Other trials in United States

Spain4 sites, 4 recruiting

  • Glaukos Investigative Site

    Barcelona

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Madrid

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Seville

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    Zaragoza

    Study Coordinator, 949-739-8749

    Recruiting

Other trials in Spain

Germany2 sites, 2 recruiting

  • Glaukos Investigative Site

    Mainz

    Study Coordinator, 949-739-8749

    Recruiting

  • Glaukos Investigative Site

    München

    Study Coordinator, 949-739-8749

    Recruiting

Other trials in Germany

Italy1 site, 1 recruiting

  • Glaukos investigative Site

    Messina

    Study Coordinator, 949-739-8749

    Recruiting

Other trials in Italy

About this study

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)

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.

Read the 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.

Being tested
lufepirsen high dose, Vehicle, lufepirsen low dose
Keywords
PCED, Corneal Defect, PED

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lufepirsen high doseDrug

    Also called NEXAGON®

    Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

  • VehicleDrug

    Also called Placebo

    Matching vehicle without lufepirsen.

  • lufepirsen low doseDrug

    Also called NEXAGON®

    Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Study groups in NCT05966493
Study groupRoleWhat they receive
NEXAGON® (lufepirsen ophthalmic gel) High Dose ConcentrationExperimentalLufepirsen (High dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.
Receives: Drug: lufepirsen high dose
NEXAGON Vehicle (ophthalmic gel)Placebo comparatorVehicle applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.
Receives: Drug: Vehicle
NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only)ExperimentalLufepirsen (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).
Receives: Drug: lufepirsen low dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: End of Study: 28 Days after achieving re-epithelialization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start17 Aug 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05966493
Sponsor's protocol ID
GLK-601-01 (AMB-01-006)
Acronym
NEXPEDE-1
Status last verified
Jul 2025
First submitted
20 Jun 2023
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lufepirsen high dose and lufepirsen low dose in people with Persistent Corneal Epithelial Defect, run by Glaukos Corporation at 28 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Spain, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (949-739-8749, ClinicalResearch@Glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achieve Corneal Re-epithelialization Including Durability (CRC) (time frame: End of Study: 28 Days after achieving re-epithelialization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05966493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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