EXPEDE: NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Chemical and/or Thermal Injuries
Study Details
Study Description
Brief 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. It will assess the efficacy and safety of NEXAGON 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NEXAGON High Dose Concentration Applied on multiple days over a 28-day Treatment Period. If corneal re-epithelialization occurs during the Treatment Period, the treatment will be withheld and the participant will enter a 28-day Follow-up Period to assess durability of the corneal epithelium. NOTE: An additional application of open-label NEXAGON High Dose Concentration is available on the final day (Day 28) of the Treatment Period for those participants still present with a PED. |
Drug: NEXAGON High Dose Concentration
Applied under a bandage contact lens and to the fornices of the eye.
Other Names:
|
| Experimental: NEXAGON Low Dose Concentration Applied on multiple days over a 28-day Treatment Period. If corneal re-epithelialization occurs during the Treatment Period, the treatment will be withheld and the participant will enter a 28-day Follow-up Period to assess durability of the corneal epithelium. NOTE: An additional application of open-label NEXAGON High Dose Concentration is available on the final day (Day 28) of the Treatment Period for those participants still present with a PED. |
Drug: NEXAGON Low Dose Concentration
Applied under a bandage contact lens and to the fornices of the eye.
Other Names:
|
| Placebo Comparator: NEXAGON Vehicle Applied on multiple days over a 28-day Treatment Period. If corneal re-epithelialization occurs during the Treatment Period, the treatment will be withheld and the participant will enter a 28-day Follow-up Period to assess durability of the corneal epithelium. NOTE: An additional application of open-label NEXAGON High Dose Concentration is available on the final day (Day 28) of the Treatment Period for those participants still present with a PED. |
Drug: NEXAGON Vehicle
Applied under a bandage contact lens and to the fornices of the eye.
|
Outcome Measures
Primary Outcome Measures
- The proportion of subjects achieving corneal epithelial recovery, as assessed by slit lamp examination. [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 [Up to 30 days after last application of intervention]
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.
Secondary Outcome Measures
- Time to corneal epithelial recovery, as assessed by slit lamp examination. [Within 28 days]
The time (number of days) from randomization to the time of initial re-epithelialization for a cornea that remains re-epithelialized and durable for at least 28 days will be recorded following confirmation by slit lamp examination.
- Improvement from baseline of visual acuity measured by the Snellen scale. [Up to 56 days]
Improvement of visual acuity on the Snellen scale from baseline until study exit will be measured.
- The number of NEXAGON treatment doses required to achieve recovery of the corneal epithelium will be assessed. [Within 56 days]
The number of NEXAGON dose applications required to achieve corneal epithelial recovery will be recorded. Corneal epithelial recovery is defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days and will be confirmed by slit lamp examination.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female of any age.
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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.
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The PED is non-responsive to current standard of care for at least 14 days from injury.
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The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
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Providing written informed consent and ability to comply with the visit and dosing schedule.
Exclusion Criteria:
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Subjects who will be unlikely to tolerate the wearing of a Bandage Contact Lens.
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Have active ocular infection.
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Subjects with corneal perforation or impending corneal perforation.
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Subjects receiving systemic corticosteroids (equivalent to GREATER THAN 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days and will remain unchanged during the study.
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Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
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Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
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Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Edward J Holland | Edgewood | Kentucky | United States | 41017 |
Sponsors and Collaborators
- OcuNexus Therapeutics, Inc.
- Eyevance Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NEX-PED-005