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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT01616056
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of chronic graft versus host disease (GVHD) as defined by the National Institutes of Health (NIH) criteria
* Ocular symptoms of NIH eye score 2 or greater:
* Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops \> 3 x per day or punctal plugs), WITHOUT vision impairment
* Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis
* No new systemic immunosuppressive medications within 1 month prior to enrollment
* Subject has the ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
* Absolute neutrophil count \< 1000/ul
* Known hypersensitivity or allergy to contact lenses
* Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment
* Treatment with contact lenses within the previous 3 months for any indication
* Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01616056
Study Brief:
Protocol Section:
NCT01616056