The Prophylactic Use of Topical Cyclosporine A 0.05% (Restasis) to Prevent Onset and Progression of Graft-versus-host Disease-related Dry Eye
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Corneal Staining Score
研究概览
简要总结
The purpose of this study is to determine whether Restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.
详细描述
The purpose of this research study is to determine if early treatment using Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (BMT) recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •Male or female
- •At least 18 years of age
- •Approved candidate for allogeneic HSCT
- •Ability to understand and provide informed consent to participate in this study
- •Willingness to follow study instructions and likely to complete all required visits
排除标准
- •History of ocular or eyelid surgery
- •History of glaucoma or ocular hypertension
- •History of herpetic eye disease
- •Patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the investigator
- •Any ocular disorder or condition (including ocular infection, trauma, and disease) that could possibly interfere with the interpretation of the study results
- •Recent (3-month) history of wearing contact lens
- •Anticipated contact lens wear during any portion of the study
- •Recent (3-month) history of current use of topical steroids or antiglaucoma agents
- •Any punctal occlusion within 2 months of the screening visit
- •Significant sign or symptoms of dry eye (the definition of "dry eye" used for exclusion criteria is compatible with the recommendations of the NEI/Industry Workshop on Clinical Trials in Dry Eyes (Lemp, 1995) (see Appendix 1and 2))
- •History of connective tissue disease or diabetes
- •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
Cyclosporine A 0.05%
If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
干预措施: Cyclosporine A 0.05% (Drug)
Artificial Tear
If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)
The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.
干预措施: Arificial Tear (Drug)
结局指标
主要结局
Corneal Staining Score
时间窗: 18 months
Conjunctival Staining Score
时间窗: 18 Months
Incidence and Severity of Ocular Adverse Event
时间窗: 18 Months
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
次要结局
- Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire(18 Months)
- Schirmer Without Anesthesia(18 Months)
- Tear Break-up Time (TBUT)(18 Months)
- Schirmer With Anesthesia(18 Months)