NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2022-02-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Corneal Persistent Epithelial Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nexagon® (lufepirsen) High Dose Concentration

Group Type EXPERIMENTAL

Nexagon® (lufepirsen) High Dose Concentration

Intervention Type DRUG

Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.

Open-label Nexagon® (lufepirsen)

Intervention Type DRUG

Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.

Nexagon® (lufepirsen) Low Dose Concentration

Group Type EXPERIMENTAL

Nexagon® (lufepirsen) Low Dose Concentration

Intervention Type DRUG

Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.

Open-label Nexagon® (lufepirsen)

Intervention Type DRUG

Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle is administered topically in the affected eye three (3) times over 28 days.

Open-label Nexagon® (lufepirsen)

Intervention Type DRUG

Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.

Interventions

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Nexagon® (lufepirsen) High Dose Concentration

Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.

Intervention Type DRUG

Nexagon® (lufepirsen) Low Dose Concentration

Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.

Intervention Type DRUG

Vehicle

Vehicle is administered topically in the affected eye three (3) times over 28 days.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

1. Male and female of any age.
2. 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.
3. The PED is non-responsive to current standard of care for at least 14 days from injury.
4. The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
5. Providing written informed consent and ability to comply with the visit and dosing schedule.

Exclusion Criteria

1. Have active ocular infection.
2. Subjects with corneal perforation or impending corneal perforation.
3. 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.
4. Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
5. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
6. Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.

Eligible Sex

ALL

Accepts Healthy Volunteers

No