Study Title: A Phase 4 Study to Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Toyos Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Dry Eye Comfort Questionnaire, SANDE
研究概览
简要总结
Study Title: A Phase 4 Study to Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects with Dry Eye Disease
详细描述
Objectives: The primary objective of this study is to investigate the safety and efficacy of H.P. Acthar Gel 80 U/ml in subjects with a documented clinical diagnosis of dry eye disease.
Study Population: The study population will consist of subjects diagnosed with dry eye disease.
Number of Subjects: Approximately 12 subjects
Investigational Product: H.P. Acthar Gel 80 U/ml sufficient for the duration of the study will be supplied by Mallinkrodt to the enrolled subjects
Route and Duration of Administration: Product will be injected subcutaneously weekly by subjects for approximately 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At Visit 1 (Screening) individuals of either gender or race will be eligible for study participation if they
- •Provide written informed consent and HIPAA authorization prior to any study related procedures
- •Are 18 years of age or older
- •Are willing and able to follow instructions and can be present for required study visits.
- •Have documented clinical diagnosis of dry eye disease in one or both eyes.
- •Have a score of at least 40mm on the ocular discomfort scale
- •Have at least 5 spk on one or both corneas
- •Have a grade of 1 or greater in the nasal or temporal areas of one or both eyes.
- •Have normal lid anatomy.
- •Are women of child bearing potential who are not pregnant or lactating and who are either abstinent and willing to remain so for the course of the trial or have an IUD in place for at least 3 months prior and through Visit 4, barrier method with spermicide for at least 3 months prior and through Visit 4, stable hormonal contraceptive for at least 3 months prior and through Visit 4 or in a monogamous relationship with a surgically sterilized (vasectomized) partner at least 6 months prior to Visit 1 and through the course of the trial.
- •Are postmenopausal (no menstrual cycle for at least one year prior to Visit 1) or have undergone bilateral tubal ligation, hysterectomy, hysterectomy with uni or bilateral oophorectomy, or bilateral oophorectomy.
排除标准
- •In order for subjects to be eligible for the study
- •Have a known hypersensitivity or contraindication to the investigational product or their components.
- •Have used any of the following medications within 14 days prior to screening
- •a. Topical or nasal vasoconstrictors
- •Subjects can be on the following medications if they have been on a stable dose for 12 weeks topical cyclosporine, topical lifitegrast and/or topical loteprednol etabonate. Tetracycline compounds, omega 3s, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressive agents including oral corticosteroids, non-steroidals, antihistamines or mast cell stabilizers, punctal plugs, contact lens wear and glaucoma medications.
- •Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial.
- •Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit
- •Subjects with a history of herpetic keratitis.
- •Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.
研究组 & 干预措施
Acthar gel 80 U/ml
Patients who continue to experience clinically significant symptoms of dry eye disease even after utilizing traditional methods of treatment for dry eye including but not limited to artificial tears, warm compresses, topical anti-inflammatories like cyclosporine and/or lifitegrast. Patients will receive repository corticotropin intramuscular injections 80 u/ml 2-3 times weekly for up to 3 months as judged by the investigator.
干预措施: Corticotropin 80Unit/Ml Repository Injection (Drug)
结局指标
主要结局
Dry Eye Comfort Questionnaire, SANDE
时间窗: 12 weeks total. Measure is change on SANDE scale (0 is no dryness and 100mm is maximal dryness) from baseline to final value. Higher values reflect greater amounts of subjective dryness.
Subjects will be asked to subjectively rate their eye dryness at Visit 1,2 and 3. Subjects will be instructed to rate eye dryness using the scale below. The total length of the line from "no dryness" to "maximal dryness" is 100 mm. The length of the line between the "no dryness" starting point and the first point at which the subject mark crosses the line will be measured in mm. This assessment is a general assessment of the change of both eyes of dryness measure from baseline to final study visit. The measure of discomfort was for the instantaneous measurement at the time of the specific visit.
1. Conjunctival Staining With Lissamine Green
时间窗: 12 weeks total. Measure is change from baseline to final,
Change in Conjunctival staining with lissamine green.
次要结局
- Intraocular Pressure(12 weeks measuring change from baseline to final)