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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00755040
First received: September 17, 2008
Last updated: April 17, 2014
Last verified: April 2014

September 17, 2008
April 17, 2014
October 2008
October 2014   (final data collection date for primary outcome measure)
Number of patients who develop ocular GVHD while on study in the two arms (ocular cyclosporine (Restasis) vs. placebo) [ Time Frame: 1 year after transplant. ] [ Designated as safety issue: No ]
Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were <5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.
Efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00755040 on ClinicalTrials.gov Archive Site
Numerical score of Ocular Surface Disease Index (OSDI) and development or lack of ocular GVHD (by ophthalmologic examination) as measured by Odds ratio in a linear regression model. [ Time Frame: 1 year after transplant ] [ Designated as safety issue: No ]
OSDI is a patient reported questionnaire consisting of 12 questions which are scored from 0 to 4. The total scored is computed and depending on the number of questions answered scores are computed which are then categorized into mild, moderate or severe dry eye symptoms. This tool should adequately reflect the morbidity of the dry eye symptoms.
Correlation between Ocular Surface Disease Index and ophthalmologic examination [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation

RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.

PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work 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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Drug: cyclosporine ophthalmic emulsion
    Given as eye drops
  • Other: placebo
    Given as eye drops
  • Experimental: Arm I
    Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
    Intervention: Drug: cyclosporine ophthalmic emulsion
  • Placebo Comparator: Arm II
    Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.
    Intervention: Other: placebo
Dietrich-Ntoukas T, Cursiefen C, Westekemper H, Eberwein P, Reinhard T, Bertz H, Nepp J, Lawitschka A, Heiligenhaus A, Seitz B, Messmer EM, Meyer-ter-Vehn T, Basara N, Greinix H, Datiles MB, Lee SJ, Pavletic SZ, Wolff D. Diagnosis and treatment of ocular chronic graft-versus-host disease: report from the German-Austrian-Swiss Consensus Conference on Clinical Practice in chronic GVHD. Cornea. 2012 Mar;31(3):299-310. doi: 10.1097/ICO.0b013e318226bf97.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
165
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00755040
VICC BMT 0766, P30CA068485, VU-VICC-BMT-0766, VU-080786
Yes
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Madan Jagasia, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP