Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Glia, LLC
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Modified SANDE Questionnaire - Frequency, Change From Baseline
研究概览
简要总结
To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.
详细描述
Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients.
A controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill.
Potential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomized double-masked parallel treatment assignment will be made using a block design at the ratio of 2:1, study drug:placebo, (22 subjects:11 subjects). This 70-day double-masked phase will be followed by 6 weeks open-label active drug treatment of the subjects previously on placebo.
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 of any race, at least 18 years of age at Visit 1 Screening.
- •Has the diagnosis of chronic ocular GvHD.
- •Has an NIH Consensus Eye Score of at least
- •On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more.
- •One or more signs from the list of chronic ocular GvHD signs below
- •Has provided verbal and written informed consent.
- •Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.
排除标准
- •Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study.
- •Anticipate major changes in systemic GvHD management during study period.
- •Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia.
- •Anticipate change of vision correction or anticipate any ocular procedures during study period.
- •A woman who is pregnant, nursing an infant, or planning a pregnancy.
- •A woman of childbearing potential who has a positive urine pregnancy test at Visit 1, or who does not use an adequate method of birth control throughout the study period.
- •Has a known adverse reaction and/or sensitivity to the study drug or its components.
- •Unwilling to cease the use of sunscreen on the forehead or eye area.
- •Intraocular pressure >22 mm Hg at screening visit with or without ongoing glaucoma treatment.
- •Currently enrolled in an investigational drug or device study for chronic ocular GvHD.
研究组 & 干预措施
Pro-ocular™
Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.
干预措施: Pro-ocular™ topical gel (Drug)
Placebo
Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.
干预措施: Placebo topical gel (Drug)
结局指标
主要结局
Modified SANDE Questionnaire - Frequency, Change From Baseline
时间窗: 2 weeks
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Corneal Fluorescein Stain - Central, Change From Baseline
时间窗: 2 weeks
Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
次要结局
- Modified SANDE Questionnaire - Frequency, Change From Baseline(10 weeks)
- Corneal Fluorescein Stain - Central, Change From Baseline(10 weeks)
- Modified SANDE Questionnaire - Global, Change From Baseline(10 weeks)
- Corneal Fluorescein Stain - Total, Change From Baseline(10 weeks)
- Blurred Vision, Change From Baseline(10 weeks)
- Photophobia, Change From Baseline(10 weeks)
- Lid Edema, Change From Baseline(10 weeks)
- Lid Erythema, Change From Baseline(10 weeks)
- Lid Margin Ulceration, Change From Baseline(10 weeks)
- Conjunctival Hyperemia, Change From Baseline(10 weeks)
- Dryness, Change From Baseline(10 weeks)
- Ocular Pain, Change From Baseline(10 weeks)
- Airflow Sensitivity, Change From Baseline(10 weeks)