NCT07268599Enrolling By Invitation不适用
Acoltremon Symptom Tracking and Relief Assessment in Moderate-to-Severe Dry Eye Disease
Colvard Kandavel Eye Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in Ocular Surface Disease Index at 28 days
研究概览
简要总结
To evaluate the impact of Acoltremon 0.003% on subjective dry eye symptoms using validated patient-reported outcome measures: Eye Dryness Score Visual Analog Scale (EDS-VAS). The primary aim is to characterize the rapidity of symptomatic relief in moderate to severe dry eye disease (DED), with attention to short-term therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older with clinical diagnosis of DED within past 6 months
- •Use or desire for artificial tears for DED symptoms within past 2 months
- •OSDI score >25 and <50 at Screening
- •TBUT <10 seconds
- •Baseline tCFS score ≥2 and ≤15 (modified NEI)
排除标准
- •History of corneal or conjunctival surgery
- •History of herpes zoster ophthalmicus, herpes simplex virus keratitis, or other viral corneal infection
- •History of neurotrophic keratitis
- •Prior significant facial trauma or sinus surgery
- •Mental or physical condition impairing ability to complete questionnaires
- •Use of Restasis®, Xiidra®, or Miebo within 30 days
- •Use of other topical anti-inflammatory medications within 30 days
- •Use of varenicline nasal spray within 30 days
- •Use of artificial tears within 2 hours prior to screening or during study period
- •Glaucoma requiring topical therapy
- •Contact lens or eyelid scrub use within 7 days
- •Punctal plugs within 14 days
- •Oxervate historical use
- •Amniotic membrane or Serum Tears historical use
- •History of Sjögren's disease
- •History of LASIK within 1 year
结局指标
主要结局
Change from baseline in Ocular Surface Disease Index at 28 days
时间窗: Baseline and 28 days
Change from baseline in specific 1-5 categorical rating scale scoring at 28 days of dry eye symptoms: Blurriness, burning/stinging, eye irritation/discomfort, photophobia/pain, tired eyes/eye fatigue, sandy/gritty/foreign body sensation
次要结局
未报告次要终点
研究者
Ganesha Kandavel
Principal Investigator
Colvard Kandavel Eye Center
研究点 (1)
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