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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07329569
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Unilateral or bilateral chemical burn of the ocular surface
* Severe ocular chemical burn of at least one eye, classified as stage VI according to the Dua severity classification (involving the entire limbus and conjunctiva)
* Time from chemical injury to enrollment ≤ 15 days
* Patient has received full study information and has provided written informed consent
* Affiliated with or beneficiary of a social security or health insurance system
Exclusion Criteria:
* Imminent corneal perforation (loss of more than two-thirds of corneal thickness)
* Ocular infection
* Eyelid tissue loss with permanent corneal exposure
* Known allergy or hypersensitivity to human albumin preparations
* History of total or partial limbal stem cell deficiency prior to the chemical injury
* Uncontrolled glaucoma prior to the ocular burn
* Recipient of a solid organ or cell transplant
* Severe or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, or cardiac disease, or any uncontrolled intercurrent illness
* Active infection, including chronic or localized infections
* History of malignancy (except completely resected localized basal cell carcinoma of the skin or cervical carcinoma in situ) within the past 5 years, whether treated or untreated, with or without evidence of recurrence or metastasis at screening
* Current treatment with systemic immunosuppressive medications (including systemic corticosteroids, TNF-α antagonists, azathioprine, methotrexate, mycophenolate mofetil)
* Adults under legal protection, individuals deprived of liberty by judicial or administrative decision, individuals receiving compulsory psychiatric care, or individuals admitted to a health or social care institution for purposes other than research
* Pregnant or breastfeeding women
* Women of childbearing potential who do not agree to use effective contraception throughout the study period (up to 12 months after the last injection)
* Participation in another interventional clinical trial during the study follow-up period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07329569
Study Brief:
Protocol Section:
NCT07329569