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 @ 12:23 PM
Ignite Modification Date:
2025-12-24 @ 12:23 PM
NCT ID:
NCT04169061
Eligibility Criteria:
Inclusion Criteria:
* Has severe or recalcitrant keratitis
* Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
* If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
* Has normal eyelids, and protocol-defined physical and medical eye attributes
* Agrees to avoid wearing contact lenses during the trial
Exclusion Criteria:
* Is pregnant or breast-feeding
* Is defined as vulnerable, or is employed by, or related to anyone involved in the study
* Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04169061
Study Brief:
Protocol Section:
NCT04169061