Cyclosporine Eye Drops 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

OBJECTIVES:

Primary

- 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
failure disorders.

Secondary

- 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
clinically necessary.

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