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Clinical Trial NU VCC11CC01

Title
Randomized Placebo Controlled Double-Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation
Principal Investigator
Surendra Basti
Details
  • Status: CLOSED
  • Study Type: Therapeutic, Symptom Management
  • Protocol No:.NU VCC11CC01
Purpose
The purpose of this study is to see how effective Restasis is in the prevention of ocular graft-versus-host disease (GVHD).
Overview
Participants in this study have had a stem cell transplant from a donor (allogeneic transplant). People who have had an allogeneic transplant are at risk of getting chronic graft-versus-host disease (cGVHD). Dry eye is one of the symptoms of cGVHD of the eye. The study drug, called Restasis, is approved by the Food and Drug Administration (FDA) in the non-transplant population to help increase the production of tears. The use of Restasis in the transplant population is investigational, meaning non-FDA approved.
Eligibility
Some of the eligibility criteria include:
  • Participant must be at least 18 years of age.
  • Participant must not have a diagnosis of ocular GVHD at time of study enrollment.
  • Participants in this study must have had a stem cell transplant from a donor.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants will receive either Restasis or placebo. This is a blinded and randomized study, which means each participant will be assigned by chance to either Restasis® or placebo, a substance with no active medicine. Neither participant, nor doctor, will know which group is the participant is in. Participants will place one drop of Restasis or placebo in each eye twice a day until the end of the study (1 year after transplant).
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 02-Oct-14 07:26 AM

 

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