Last reviewed · How we verify
NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries
Phase 2 trial testing Nexagon® (lufepirsen) High Dose Concentration in Corneal Persistent Epithelial Defect in 35 participants. Terminated before completion.
| Lead sponsor | Glaukos Corporation |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 30 June 2020 |
| Primary completion | 7 February 2022 |
| Estimated completion | 7 February 2022 |
| Sites | 1 location across United States |
Glaukos Corporation — full company profile →
Eligibility, any sex, with Corneal Persistent Epithelial Defect. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Nexagon® (Lufepirsen) High Dose Concentration | 8 | |
| Nexagon® (Lufepirsen) Low Dose Concentration | 8 | |
| Vehicle | 3 |
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.
| Group | Value | 95% CI |
|---|---|---|
| Nexagon® (Lufepirsen) High Dose Concentration | 7 | |
| Nexagon® (Lufepirsen) Low Dose Concentration | 8 | |
| Vehicle | 7 |
Time frame: 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nexagon® (Lufepirsen) High… | Nexagon® (Lufepirsen) Low … | Vehicle |
|---|---|---|---|---|
| Cicatricial ectropion with lateral lagophthalmos and exposed lacrimal gland | Eye disorders | — | — | — |
| Reaction | System | Nexagon® (Lufepirsen) High… | Nexagon® (Lufepirsen) Low … | Vehicle |
|---|---|---|---|---|
| Symblepharon | Eye disorders | — | — | — |
| Corneal epithelium defect | Eye disorders | — | — | — |
| Eye pain | Eye disorders | — | — | — |
| Blepharitis | Eye disorders | — | — | — |
| Cataract | Eye disorders | — | — | — |
| Conjunctival hyperaemia | Eye disorders | — | — | — |
| Corneal neovascularisation | Eye disorders | — | — | — |
| Corneal thinning | Eye disorders | — | — | — |
| Dry eye | Eye disorders | — | — | — |
| Ectropion | Eye disorders | — | — | — |
| Eye irritation | Eye disorders | — | — | — |
| Eye pruritus | Eye disorders | — | — | — |
| Lacrimation increased | Eye disorders | — | — | — |
| Ocular hyperaemia | Eye disorders | — | — | — |
| Visual impairment | Eye disorders | — | — | — |
| Hyperplasia | General disorders | — | — | — |
| Seasonal allergy | Immune system disorders | — | — | — |
| Hypopyon | Infections and infestations | — | — | — |
| Periorbital cellulitis | Infections and infestations | — | — | — |
| Eyelid scar | Injury, poisoning and procedural complications | — | — | — |
| Cataract | Eye disorders | — | — | — |
| Seasonal allergy | Immune system disorders | — | — | — |
| COVID-19 | Infections and infestations | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
Most-reported serious reactions: Cicatricial ectropion with lateral lagophthalmos and exposed lacrimal gland.
Data from ClinicalTrials.gov NCT04081103 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04081103.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing