Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2013 |
| Contact: | Cornea Research |
| Email: | Cornea_Research@meei.harvard.edu |
| Phone: | 617-573-3313 |
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). A secondary
objective is to compare the efficacy of topical tacrolimus 0.05% drops compared with topical
methylprednisolone sodium succinate 0.5% drops in patients with ocular GVHD. 40 patients
with ocular GVHD who meet the inclusion criteria of the study as determined by a screening
visit will be divided into two equal groups. In addition to their current medication, one
group will receive the topical tacrolimus 0.05% drops and the other group will receive the
topical methylprednisolone sodium succinate 0.5% drops. The participants will then have two
follow-up visits at the week 5 and week 10 markers after their screening visit.
To evaluate the purpose of the study as well as the patient's safety, the following
procedures will be performed at each visit: a comprehensive eye examination, tear break-up
time (TBUT), Schirmer's test, intraocular pressure (IOP), fundoscopy and grading scores of
lid margin and corneal fluorescein staining. The following questionnaires will be
administered at each visit: Ocular Surface Disease Index (OSDI) and Symptom Assessment in
Dry Eye (SANDE). Impression cytology specimens will be taken only at the screening visit and
at the week 10 visit.
0.05% twice a day in the treatment of ocular graft versus host disease (GVHD). A secondary
objective is to compare the efficacy of topical tacrolimus 0.05% drops compared with topical
methylprednisolone sodium succinate 0.5% drops in patients with ocular GVHD. 40 patients
with ocular GVHD who meet the inclusion criteria of the study as determined by a screening
visit will be divided into two equal groups. In addition to their current medication, one
group will receive the topical tacrolimus 0.05% drops and the other group will receive the
topical methylprednisolone sodium succinate 0.5% drops. The participants will then have two
follow-up visits at the week 5 and week 10 markers after their screening visit.
To evaluate the purpose of the study as well as the patient's safety, the following
procedures will be performed at each visit: a comprehensive eye examination, tear break-up
time (TBUT), Schirmer's test, intraocular pressure (IOP), fundoscopy and grading scores of
lid margin and corneal fluorescein staining. The following questionnaires will be
administered at each visit: Ocular Surface Disease Index (OSDI) and Symptom Assessment in
Dry Eye (SANDE). Impression cytology specimens will be taken only at the screening visit and
at the week 10 visit.
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.
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