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Not Recruiting
Trial ID: NCT00755040
Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
Inclusion criteria:
- 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
Exclusion criteria:
- history of non-compliance
- 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: placebo
drug: cyclosporine ophthalmic emulsion
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
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