A Longitudinal, Open-label, Multi-center Study to Explore the Relationship Between Signs, Symptoms, Molecular and Imaging Biomarkers in Participants With Dry Eye Disease Following Anti-inflammatory Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 14
- 主要终点
- Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein
研究概览
简要总结
This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants).
详细描述
This study aims to characterize longitudinal changes in signs, symptoms, molecular, and imaging markers of the ocular surface to investigate pathological mechanisms and biomarkers (BMs) of DED after treatment with either of two commercially approved therapeutics (Vevye® [cyclosporine ophthalmic solution], Xiidra® [liftegrast ophthalmic solution]).
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
- None
盲法说明
This is a partially masked study where health care professionals conducting the ocular assessments will be masked to treatment assignment but not to study eye assignment. However, other site personnel and participants will be unmasked.
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
- •A. Inclusion Criteria for Participants with DED:
- •The participant reported dry eye-related ocular symptoms for at least 6 months before the screening visit
- •The participant must have either used lubricant eye drops regularly OR had the desire to use lubricant eye drops in the past 3 months
- •Participant must be classified as having moderate/severe DED
- •The participant is deemed by the physician to require a prescription medication for DED (e.g., cyclosporin A or lifitegrast)
- •B. Inclusion Criteria for Healthy Volunteers:
- •- The participant does not have overt clinical signs of DED in either eye
排除标准
- •Intraocular pressure (IOP) >21.00 millimeters of mercury (mmHg) in either eye
- •Acute allergic conjunctivitis in either eye within 3 months prior to screening
- •Use of contact lenses within 30 days prior to screening
- •Punctal plugs within 3 months prior to screening or any history of punctal cauterization or occlusion by an approach different from punctal plugs
- •Use of ocular anti-inflammatory agents or ocular immunosuppressive agents within 3 months prior to screening
- •Any intraocular injections (e.g., intravitreal [IVT] anti-vascular endothelial growth factor [VEGF]) within 3 months prior to screening, or such injections planned for within the study period
- •Any intraocular immunosuppressive implants within 12 months prior to screening
- •Any history of isotretinoin use within 12 months prior to screening
- •Uncontrolled ocular or systemic disease
研究组 & 干预措施
Vevye®
Participants with evaporative dry eye (EDE), aqueous deficient dry eye (ADDE) and mixed dry eye will receive Vevye®, 1 milligrams per milliliter (mg/mL) as one drop into the affected eye(s), twice daily (BID) via topical ocular instillation for 12 weeks.
干预措施: Vevye® (Drug)
Xiidra®
Participants with EDE, ADDE, and mixed dry eye will receive Xiidra®, 50 mg/mL as one drop into the affected eye(s), BID via topical ocular instillation for 12 weeks.
干预措施: Xiidra® (Drug)
Healthy Cohort
Healthy volunteers will be enrolled as a control group and will not receive any treatment.
结局指标
主要结局
Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein
时间窗: Up to Week 12
次要结局
未报告次要终点