A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 10
- 主要终点
- Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
研究概览
简要总结
A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGHVD)
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
- 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
- •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.
- •Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
- •Minimum Oxford Schema grad of ≥ 1 in at least one eye.
- •OSDI scored of ≥
- •UNC DEMS score of ≥
- •In good stable overall health.
排除标准
- •History of Rheumatoid Arthritis, Lupus, Scleroderma.
- •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.
- •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.
- •All vaccination including COVID are prohibited during this study.
- •Signs of current infection, including fever and current treatment with antibiotics.
- •All vaccinations including COVID are prohibited during this study.
- •Intra-ocular surgery or ocular laser surgery within 3 months.
- •Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of childbearing potential, unwillingness to use effective birth control while participating in the study.
- •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
This arm randomizes the actual drug to the patient.
Based on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
干预措施: d-MAPPS (Biological)
This arm randomizes the placebo to the patient.
Based on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
干预措施: Placebo (Biological)
Both patient and PI are masked.
Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.
干预措施: d-MAPPS (Biological)
Both patient and PI are masked.
Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.
干预措施: Placebo (Biological)
Both patient and PI are masked.
Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.
干预措施: PI and Patient Masked (Other)
结局指标
主要结局
Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
时间窗: Through study completion, an average of 4 months.
The UNC Dry Eye Management Scale (DEMS) helps evaluate different aspects of DED, including symptoms, severity, and impact on daily life. Dry eye symptoms such as grittiness, dryness, foreign body sensation, redness, tearing, and irritation. The UNC DEMS is used in clinical settings to inform treatment decisions and monitor the effectiveness of interventions. UNC DEMS scores are on a scale from 1-10, with 10 being the most severe. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90 ±5 days.
Changes from Baseline utilizing Ocular Surface Disease Index (OSDI)
时间窗: Through study completion, an average of 4 months.
Ocular Surface Disease Index (OSDI) Questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale. The results are calculated in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90 ±5 days.
次要结局
- Changes from baseline utilizing the NIH Eye Score for chronic oGVHD(Through study completion, an average of 4 months.)
- Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades(Through study completion, an average of 4 months.)