Corneal Persistent Epithelial DefectPhase 2EXPEDENCT04081103
NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries
A Phase 2 study testing Nexagon® (lufepirsen) High Dose Concentration, Nexagon® (lufepirsen) Low Dose Concentration and Open-label Nexagon® (lufepirsen) in people with Corneal Persistent Epithelial Defect, run by Glaukos Corporation at 1 site in United States.
Trial summary
This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Persistent Epithelial Defect
- What is being tested?
- Nexagon® (lufepirsen) High Dose Concentration, Nexagon® (lufepirsen) Low Dose Concentration and Open-label Nexagon® (lufepirsen)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2020to 7 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female of any age.
- The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
- The PED is non-responsive to current standard of care for at least 14 days from injury.
- The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
- Providing written informed consent and ability to comply with the visit and dosing schedule.
Who cannot join
- Have active ocular infection.
- Subjects with corneal perforation or impending corneal perforation.
- Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
- Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
- Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
- Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jules Stein Eye Institute
Los Angeles, California, 90095
About this study
Official title: A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) in Subjects With Corneal Persistent Epithelial Defects
This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.
- Conditions
- Corneal Persistent Epithelial Defect
- Being tested
- Nexagon® (lufepirsen) High Dose Concentration, Nexagon® (lufepirsen) Low Dose Concentration, Vehicle, Open-label Nexagon® (lufepirsen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexagon® (lufepirsen) High Dose ConcentrationDrug
Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.
Nexagon® (lufepirsen) Low Dose ConcentrationDrug
Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.
VehicleDrug
Also called Placebo
Vehicle is administered topically in the affected eye three (3) times over 28 days.
Open-label Nexagon® (lufepirsen)Drug
Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| Nexagon® (lufepirsen) High Dose Concentration | Experimental | Not described Receives: Drug: Nexagon® (lufepirsen) High Dose Concentration; Drug: Open-label Nexagon® (lufepirsen) |
| Nexagon® (lufepirsen) Low Dose Concentration | Experimental | Not described Receives: Drug: Nexagon® (lufepirsen) Low Dose Concentration; Drug: Open-label Nexagon® (lufepirsen) |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle; Drug: Open-label Nexagon® (lufepirsen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.
Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination.
Measured: Up to 56 days.
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.
Measured: Up to 30 days after last application of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start30 Jun 2020
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Why it stopped: The study was stopped early (n=35) enabling the data to guide design of the subsequent clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal Persistent Epithelial DefectStudies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amber Ophthalmics, Inc.
- Responsible party
- Sponsor
- Investigators
- Maria Feldman, Study director, Amber Ophthalmics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081103
- Sponsor's protocol ID
- NEX-PED-005
- Acronym
- EXPEDE
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2019
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) in Subjects With Corneal Persistent Epithelial Defects
- ClinicalTrials.gov ID
- NCT04081103
- Acronym / sponsor ID
- EXPEDE / NEX-PED-005
- Conditions
- Corneal Persistent Epithelial Defect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early (n=35) enabling the data to guide design of the subsequent clinical study.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Amber Ophthalmics, Inc.
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nexagon® (lufepirsen) High Dose Concentration | Experimental | Drug: Nexagon® (lufepirsen) High Dose Concentration, Drug: Open-label Nexagon® (lufepirsen) |
| Nexagon® (lufepirsen) Low Dose Concentration | Experimental | Drug: Nexagon® (lufepirsen) Low Dose Concentration, Drug: Open-label Nexagon® (lufepirsen) |
| Vehicle | Placebo comparator | Drug: Vehicle, Drug: Open-label Nexagon® (lufepirsen) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female of any age.
- The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
- The PED is non-responsive to current standard of care for at least 14 days from injury.
- The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
- Providing written informed consent and ability to comply with the visit and dosing schedule.
Key exclusion criteria (6 listed)
- Have active ocular infection.
- Subjects with corneal perforation or impending corneal perforation.
- Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
- Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
- Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexagon® (lufepirsen) High Dose ConcentrationNexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. | Drug | Nexagon® (lufepirsen) High Dose Concentration |
| Nexagon® (lufepirsen) Low Dose ConcentrationNexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days. | Drug | Nexagon® (lufepirsen) Low Dose Concentration |
| VehicleAlso: PlaceboVehicle is administered topically in the affected eye three (3) times over 28 days. | Drug | Vehicle |
| Open-label Nexagon® (lufepirsen)Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase. | Drug | Nexagon® (lufepirsen) High Dose Concentration, Nexagon® (lufepirsen) Low Dose Concentration, Vehicle |
Primary outcome
The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.
Time frame: Up to 56 days.
Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination.
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0
Time frame: Up to 30 days after last application of intervention
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Feldman study director
Amber Ophthalmics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexagon® (lufepirsen) High Dose Concentration, Nexagon® (lufepirsen) Low Dose Concentration and Open-label Nexagon® (lufepirsen) in people with Corneal Persistent Epithelial Defect, run by Glaukos Corporation at 1 site in United States.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 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 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination. (time frame: Up to 56 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.