Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation
研究概览
简要总结
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).
详细描述
The objective of this study is to compare the safety and 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •In good stable overall health.
排除标准
- •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 >1mm
- •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.
研究组 & 干预措施
Tacrolimus
Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
干预措施: Tacrolimus (Drug)
Methylprednisolone Sodium Succinate
Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.
干预措施: Methylprednisolone Sodium Succinate (Drug)
结局指标
主要结局
Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation
时间窗: 10 weeks
Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured 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. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability).
次要结局
- Tear Film Break-Up Time(10 weeks)
- Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)(10 weeks)
- Schirmer Tear Test (mm)(10 weeks)
- Ocular Surface Disease Index (OSDI) Questionnaire(10 weeks)
- Visual Acuity(10 weeks)
- Intraocular Pressure(10 weeks)
研究者
Reza Dana, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary