Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
- To assess the efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the
prevention of ocular graft-versus-host disease in patients who have undergone
allogeneic stem cell transplantation for hematologic malignancies or bone marrow
- To correlate the Ocular Surface Disease Index with clinical ophthalmologic examination.
OUTLINE: This is a multicenter study. Patients are stratified according to age, type of
transplant (related vs unrelated), and intensity of transplant (ablative vs other). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye
twice daily for up to 1 year after transplant.
- Arm II: Patients receive placebo ophthalmic drops in each eye twice daily for up to 1
year after transplant.
Patients in both arms may also receive artificial tear drops at least twice daily as
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease
1 year after transplant.
Madan Jagasia, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC BMT 0766
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Stanford University||Stanford, California 94305|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|
|Norwestern Memorial Hospital||Chicago, Illinois 60611|