Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
Condition: Ocular GVHD
MeSH terms: Graft vs Host Disease
Intervention: Tacrolimus; Methylprednisolone Sodium Succinate
Intervention description: Topical bilateral application of 0.05% Tacrolimus BID for 10 weeks; Topical bilateral application of 0.5% methylprednisolone sodium succinate BID for 10 weeks
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Tacrolimus; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GVHD; Ocular GVHD; Tacrolimus; Methylprednisolone

Summary:

      The purpose of this study is to evaluate the safety and tolerability of topical tacrolimus
      0.05% twice a day in the treatment of ocular graft versus host disease (GVHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years.

          -  Willing and able to provide written informed consent.

          -  Willing and able to comply with study assessments for the full duration of the study.

          -  Diagnosis of ocular GVHD.

          -  Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one
             eye.

          -  Ocular Surface Disease Index score >22.

          -  In good stable overall health.

        Exclusion Criteria:

          -  History of immune disease other than GVHD.

          -  Ocular or periocular malignancy.

          -  Significant change, as judged by the principal investigator, in systemic
             immunosuppressive regimen within 2 weeks of study entry.

          -  Any history of topical tacrolimus use.

          -  Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and
             minocycline) within the last month.

          -  Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study
             entry.

          -  Current use of topical steroids more than twice a day.

          -  Change in frequency of serum tears, topical cyclosporine and/or topical kineret within
             the last month.

          -  Corneal epithelial defect >1mm2.

          -  Any history of herpetic keratitis.

          -  Participation in another simultaneous medical research study.

          -  Signs of current infection, including fever and current treatment with antibiotics.

          -  Intra-ocular surgery or ocular laser surgery within 3 months.

          -  Pregnancy (positive pregnancy test) or lactating

          -  Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens,
             for the last 2 weeks prior to the study or would be unable to stay off contact lenses
             for the study duration.

          -  Any condition (including language barrier) that precludes patient's ability to comply
             with study requirements including completion of study.