The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study: An Investigation on Lifitegrast's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change in corneal higher order aberrations
研究概览
简要总结
In patients with dry eye, defined as corneal staining and a reduced tear breakup time, lifitegrast will improve higher order aberrations, ocular scatter index, corneal staining, and TBUT as soon as 1 week after initiating treatment.
详细描述
This is a multicenter, prospective, open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days
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
- •Central or inferior corneal fluorescein staining defined by the Oxford Scale
- •Reduced tear break up time (TBUT) ≤ 10 seconds.
- •Able to comprehend and sign a statement of informed consent.
- •Willing and able to complete all required postoperative visits.
排除标准
- •Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed in the study eye within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- •Clinically significant ocular trauma.
- •Active ocular Herpes simplex or Herpes Zoster infection
- •Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) that is active, at the discretion of the investigator.
- •Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye), at the discretion of the investigator.
- •Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings, in the opinion of the investigator.
- •Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis that would interfere with study findings, in the opinion of the investigator.
- •Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- •Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that would interfere with study findings, in the opinion of the investigator.
- •Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
- •Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
研究组 & 干预措施
Single /arm
All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.
干预措施: Lifitegrast 5% Ophthalmic Solution (Drug)
结局指标
主要结局
Change in corneal higher order aberrations
时间窗: After 7, 14, and 28 days of treatment.
Change in corneal higher order aberrations after 7, 14, and 28 days of treatment.
次要结局
- Change in OSI after 7, 14, and 28 days of treatment.(After 7, 14, and 28 days of treatment.)