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Complete title: A Randomized Placebo Controlled Double-Blind Study of Restasis® Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
|Research Study Number||2321.00|
|Principal Investigator||Mary Flowers, MD|
Research Study Description
PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work in preventing graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Age greater than or equal to 18 years at time of enrollment
- Day 80-120 after first allogeneic stem cell transplant for hematologic malignancies or -marrow failure disorder at time of study enrollment
- Signed informed consent
- Willing to adhere to protocol requirements
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- diagnosis of ocular GVHD at time of study enrollment
- documented dry eye prior to onset of stem cell transplant
- significant non- GVHD ocular problems that precludes participation in study
- life expectancy of lesser than 6 months at time of enrollment (viz. grade 4 acute GVHD, florid progression or relapse of underlying disease)
- history of documented ocular infections prior to stem cell transplant or during transplant (i.e. history of herpetic keratitis)
- females who are pregnant or breastfeeding
Other exclusion criteria may apply.
Leukemia; Lymphoma; Chronic Graft Versus Host Disease (cGVHD)
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