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

Completed · Phase 1

Conditions studied: Ocular GVHD

In brief

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).

Key facts

Study ID

NCT01977781

Run by

Massachusetts Eye and Ear Infirmary

People needed

40

Starts

2013-12-01

Expected to finish

2014-09-01

Last updated by the study team

2017-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.