Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT04081103
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04081103
Study Brief:
Protocol Section:
NCT04081103