Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus

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.