NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries (NCT04081103) | Clinical Trial Compass
TerminatedPhase 2
NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries
Stopped: The study was stopped early (n=35) enabling the data to guide design of the subsequent clinical study.
United States35 participantsStarted 2020-06-30
Plain-language 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® (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.
Who can participate
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.
Timeframe: Up to 56 days.
2
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0
Timeframe: Up to 30 days after last application of intervention