NCT07560735尚未招募4 期
Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy (IVCM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Toyos Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in immune cell density in subjects with dry eye disease treated with lifitegrast
研究概览
简要总结
This is a single center, open label trial to evaluate Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease using In Vivo Confocal Microscopy (IVCM
详细描述
Approximately 30 subjects with dry eye disease (DED) will be treated with Xiidra® to evaluate the effects of lifitegrast on the ocular surface using in vivo confocal microscopy.
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
- 否
入选标准
- •1. Subject can read, understand and sign an informed consent letter.
- •Provision of signed and dated informed consent form and HIPAA authorization.
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female at least 18 years of age at the time of enrollment
- •Minimum corneal staining of ≥2 or greater according to the NEI grading scale in the lower corneal subregion.
- •Normal eyelids and corneal anatomy
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration
- •For males of reproductive potential: should be able to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP) NOTE: Acceptable forms of birth control include:
- •True abstinence (when this is in line with the preferred and usual lifestyle of the subject), or
- •Vasectomy at least 3 months prior to the first dose of study drug
- •Without a vasectomy, must use condoms with spermicidal foam, gel, film, cream, suppository at least 14 days prior to the first dose of investigational drug and throughout the study duration, and for 4 weeks after the last dose of the investigational drug.
- •Or the female partner of the male investigational subject, must comply with the previous points.
- •9. 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 for 1 year prior to study start.
- •10. Best corrected visual acuity of 0.7 logMAR or better (Snellen equivalent score of 20/100 or better) in each eye at day -14 (Visit 1) and Day 0 (Visit 2)
- •Subject-reported history of dry eye for at least 6 months.
- •Schirmer Tear Test (without anesthesia) ≥1mm and ≤10mm at baseline
- •EDS score of ≥40 (0-100-point VAS, both eyes) value is an average at screening and baseline.
排除标准
- •1. Have a known hypersensitivity or contraindication to the product or their components.
- •Unwilling to discontinue contact lens use for the duration of the study
- •Pregnancy or lactation
- •Have used topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from the same during study period
- •Subjects that use topical steroids, systemic immunosuppressive agents including oral corticosteroids, antihistamines, mast cell stabilizers or glaucoma medications.
- •6. Subjects unwilling to abstain from eyelash growth products containing prostaglandins for the duration of the trial.
- •7. Subjects who had ocular surgery within the past 1 year prior to Visit
- •Febrile illness within one week.
- •Active or history of infectious keratitis; any other ocular infection within the last 30 days
- •Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.
- •11. Use of new prescription eyedrop within 30 days of screening
- •Change in systemic medication within 30 days of screening
- •Any subject who has previously tried and failed a course of lifitegrast.
- •Subjects with secondary Sjogren's syndrome (ex. Rheumatoid arthritis, systemic lupus, erythematosus) or other autoimmune disease (ex: multiple sclerosis, inflammatory bowel disease) are eligible for enrollment consideration provided the subject met all other inclusion and exclusion criteria, AND, were not in a medical state in the opinion of the principle investigator that could have interfered with the study parameters, were not taking systemic/ocular steroids and were not immunodeficient/immunosuppressed (ex: receiving systemic immunomodulating or immunosuppressive drugs to manage their baseline medical state.)
研究组 & 干预措施
DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra)
Experimental
30 subjects with DED receiving lifitegrast ophthalmic solution 5.0% (Xiidra)
干预措施: Lifitegrast Ophthalmic Solution 5.0% (Xiidra) (Drug)
结局指标
主要结局
Change in immune cell density in subjects with dry eye disease treated with lifitegrast
时间窗: 84 days
Change from baseline (Day 0) immune cell density, as measured by in vivo confocoal microscopy (IVCM), in subjects with dry eye disease treated with Xiidra (Lifitegrast Opthalmic Solution 5.0%), at Day 84.
次要结局
未报告次要终点
研究者
研究点 (1)
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