Ocular GVHD Clinical Trial
Official title:
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
| NCT number | NCT01977781 |
| Other study ID # | 13-067H |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 1 |
| First received | October 31, 2013 |
| Last updated | April 18, 2014 |
| Start date | December 2013 |
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts Eye and Ear Infirmary |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. | Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. The severity of each adverse event and relation to the study medication will be graded possibly, probably, or definitely related. Tolerability measures will be graded from trace to severe using a direct query method at each visit. | 10 weeks | Yes |
| Secondary | To compare the efficacy of topical tacrolimus 0.05% twice a day to the efficacy of topical methylprednisolone sodium succinate 0.5% twice a day in reducing signs and symptoms of dry eye in patients with ocular GVHD. | Comparison of the efficacy of topical tacrolimus 0.05% and topical methylprednisolone sodium succinate 0.5% in reducing ocular signs and symptoms. Signs and symptoms will be evaluated using the following methods: Ocular Signs Corneal epitheliopathy (corneal fluorescein staining using the NEI grading scheme). Tear Film Break Up Time (TBUT) Schirmer's Test I Expression of cellular markers of inflammation (HLA DR, ICAM-1, IL-1b, IL-2, IL-6, IL-8, IL-10, IL-17, IL-23, IFN-g and TNF-a) using real-time polymerase chain reaction (RT-PCR) and flow cytometry (FC), on impression cytology specimens. Ocular Symptoms Ocular Surface Disease Index (OSDI) questionnaire. Symptom Assessment in Dry Eye (SANDE) questionnaire. |
10 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients
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