Ocular GVHD Clinical Trial
Official title:
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04700657 -
The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients
|