Status:
TERMINATED
NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries
Lead Sponsor:
Glaukos Corporation
Collaborating Sponsors:
Amber Ophthalmics, Inc.
Conditions:
Corneal Persistent Epithelial Defect
Eligibility:
All Genders
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04081103
Start Date
June 30 2020
End Date
February 7 2022
Last Update
July 14 2025
Active Locations (1)
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1
Jules Stein Eye Institute
Los Angeles, California, United States, 90095