NCT07128628已完成2 期
A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 32
- 主要终点
- Total corneal fluorescein staining change from baseline
研究概览
简要总结
A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
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
- Double (Participant, Investigator)
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
- •This study will include subjects who meet all of the following inclusion criteria:
- •Voluntarily provide written informed consent
- •≥18 years of age
- •Subject-reported history of DED OU for at least 6 months
- •Same eye satisfies the criteria for dry eye signs at both screening and baseline/randomization
- •The criteria for dry eye symptoms are met at both screening and baseline/randomization
- •As needed (PRN) or scheduled use of non-prescription (OTC) artificial tear, gels, or lubricants for symptoms of dry eye within the past 30 days
- •Able and willing to follow instructions, including participation in all trial assessments and visits
排除标准
- •This study will exclude subjects who meet any of the following exclusion criteria (Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study):
- •Known allergy or sensitivity to any study treatment (or any of its components)
- •Best-corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or worse (50 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening) or Visit 2 (baseline/randomization)
- •Any clinically significant (CS) ocular surface slit-lamp findings at Visit 1 (Screening) or Visit 2 (baseline/randomization), or findings that may interfere with trial parameters in the opinion of the Investigator.
- •Use of any of any ocular therapies within 30 days.
- •Unable or unwilling to stop current topical dry eye treatments
- •Additional criteria per protocol
研究组 & 干预措施
Arm 1
Experimental
干预措施: Lifitegrast/Perfluorohexyloctane Fixed Dose Combination (Drug)
Arm 4
Placebo Comparator
干预措施: Vehicle (Drug)
Arm 5
Placebo Comparator
干预措施: Vehicle (Drug)
Arm 6
Placebo Comparator
干预措施: Vehicle (Drug)
Arm 2
Active Comparator
干预措施: Lifitegrast (Drug)
Arm 3
Active Comparator
干预措施: Perfluorohexyloctane (Drug)
结局指标
主要结局
Total corneal fluorescein staining change from baseline
时间窗: Baseline, day 29
次要结局
未报告次要终点
研究者
研究点 (32)
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