A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale
研究概览
简要总结
This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.
详细描述
PRIMARY OBJECTIVES:
I. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.
SECONDARY OBJECTIVES:
I. To confirm short-term safety within 1 month after bandage lenses.
II. To determine improvement in ophthalmologic examinations after bandage lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic graft versus host disease (GVHD) as defined by the National Institutes of Health (NIH) criteria
- •Ocular symptoms of NIH eye score 2 or greater:
- •Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops > 3 x per day or punctal plugs), WITHOUT vision impairment
- •Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis
- •No new systemic immunosuppressive medications within 1 month prior to enrollment
- •Subject has the ability to understand and willingness to sign a written informed consent document
排除标准
- •Absolute neutrophil count < 1000/ul
- •Known hypersensitivity or allergy to contact lenses
- •Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment
- •Treatment with contact lenses within the previous 3 months for any indication
- •Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol
结局指标
主要结局
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale
时间窗: 3 months
The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI
时间窗: 3 months
OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale
时间窗: 3 months
8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index
时间窗: 3 months
OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale
时间窗: 3 months
The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale
时间窗: 3 months
Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx\_eye=mean(sx6,sx7,sx8)\*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.
次要结局
- Number of Patients Who Experienced Serious Adverse Events(1 month)
- Change in Optical Coherence Tomography(2 weeks)
- Change in Comprehensive Ophthalmologic Evaluations(2 weeks)
研究者
Stephanie Lee
Principal Investigator
Fred Hutchinson Cancer Center