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Complete title: A Phase II Study of Bandage Lenses for Ocular Graft-versus-host Disease after Allogeneic Hematopoietic Cell Transplantation
|Research Study Number||2617.00|
|Principal Investigator||Stephanie Lee, MD, MPH|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Diagnosis of chronic 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
Other exclusion criteria may apply.
Chronic Graft Versus Host Disease (cGVHD)
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