Use of Restasis to Prevent Onset and Progression of Graft versus Host Disease

Graft-versus-host disease (GVHD) is a complication which sometimes develops after an allogeneic bone marrow transplant (BMT).  An allogeneic bone marrow transplant means the patient will receive harvested bone marrow from a family member or unrelated donor. GVHD occurs when immune cells in the transplanted tissue (or graft) identify cells in the patients body (the host) as foreign and attack them.

Dry Eye is a major complication associated with GVHD affecting 50% of patients with allogeneic bone marrow transplants.  People with Dry Eye often experience burning, irritation, blurred vision and gradual contact lens intolerance. Their daily activities such as reading, driving, and working may be negatively impacted.  Currently there is no preventive treatment for GVHD related Dry Eye.

This study uses a medication called Restasis. Restasis is an eye drop that increases tear production. This drug has been approved by the United States Food and Drug Administration for the treatment of Dry Eye since December 2002.  The purpose of this study is to determine if early use of Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic BMT recipients.

This is an 18 month study involving up to 6 office visits. The first visit to screen candidates will occur before any myeloablative preparative measures have taken place prior to the BMT.  The first use of Restasis eye drops will take place one month after the bone marrow transplant.