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

Launched by AMBER OPHTHALMICS, INC. · Sep 4, 2019

Keywords

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Gender

ALL

Eligibility criteria

• 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.