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:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT02561520
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years.
* Willing and able to provide written informed consent.
* Willing and able to comply with study assessments for the full duration of the study.
* Diagnosis of ocular GVHD.
* Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
* In good stable overall health.
Exclusion Criteria:
* Remission from primary cancer in more than 5 years.
* History of thrombocytopenia (platelet\<50,000) in the last 2 weeks before study entry.
* Ocular or periocular malignancy.
* Significant change, as judged by the PI, in systemic immunosuppressive regimen before 2 weeks of study entry.
* Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
* Any change in frequency of preserved anti-glaucoma medications before 2 weeks of study entry.
* Current use of topical steroids more than twice a day.
* Change in frequency of topical cyclosporine and/or topical kineret within the last month.
* Signs of current infection, including fever and current treatment with antibiotics.
* Intra-ocular surgery or ocular laser surgery within the last 3 months.
* Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens or scleral contact lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02561520
Study Brief:
Protocol Section:
NCT02561520