NCT07503886招募中2 期
A 12-Week, Phase 2, Multicenter, Randomized, Double-Masked, Vehicle Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate the Efficacy and Safety of DFL24498 0.08% Topical Ophthalmic Solution Versus Vehicle in Participants With Dry Eye Disease
Dompé Farmaceutici S.p.A24 个研究点 分布在 1 个国家目标入组 417 人开始时间: 2026年5月12日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 417
- 试验地点
- 24
研究概览
简要总结
This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.
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
- •A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye).
- •The global score of the SANDE questionnaire ≥ 30
- •DED in at least one eye which is characterized by the following clinical features:
- •Schirmer I test without anesthesia < 10 mm/5 minutes, and
- •Total CFS grade ≥ 4 assessed by the NEI grading system, and
- •Fluorescein tear film break-up time (TFBUT) < 10 seconds.
- •Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) [LogMAR]) in each eye at the time of study enrollment.
- •Only participants who satisfy all informed consent requirements will be included in the study.
排除标准
- •Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
- •Evidence of an active ocular infection in either eye.
- •Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening.
- •Intraocular inflammation defined as anterior chamber cell or flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye.
- •Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye.
- •Note: Additional protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
DFL24498
Experimental
Participants will receive DFL24498 opthalmic solution administered topically in both eyes.
干预措施: DFL24498 (Drug)
Vehicle
Placebo Comparator
Participants will receive vehicle opthalmic solution administered topically in both eyes.
干预措施: Vehicle (Other)
研究者
研究点 (24)
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