NCT06400459已完成1 期
Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Schirmer's
研究概览
简要总结
Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.
详细描述
This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-masked
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
- •Subjects of any gender at least 18 years of age at the Screening Visit
- •Able to voluntarily provide written informed consent to participate in the study
- •Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
- •Diagnosis of Dry Eye Disease (DED)
排除标准
- •Corneal fluorescein staining score of 4 using the NEI grading system
- •Intraocular pressure ≥23 mmHg
- •History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
- •Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED
研究组 & 干预措施
IVW-1001 0.1%
Experimental
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
干预措施: IVW-1001 Ophthalmic Eyelid Wipe 0.1% (Drug)
IVW-1001 0.2%
Experimental
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
干预措施: IVW-1001 Ophthalmic Eyelid Wipe 0.2% (Drug)
IVW-1001 Placebo
Placebo Comparator
Vehicle
干预措施: IVW-1001 Placebo (Drug)
结局指标
主要结局
Schirmer's
时间窗: 29 Days
Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)
次要结局
- Visual Acuity(29 Days)
- Total Corneal Fluorescein Staining Score in the Study Eye(Week 4)
- Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score(Week 4)
- Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score(4 weeks)
- Symptom Assessment in Dry Eye (SANDE): Global Score(4 weeks)
研究者
研究点 (1)
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相关资讯
IVIEW Therapeutics' Novel Dry Eye Treatment Shows Promising Results in Phase 1/2 Trial- IVW-1001, a novel TRPM8 agonist delivered via ophthalmic eyelid wipe, demonstrated significant improvements in dry eye symptoms and corneal staining in a 150-patient Phase 1/2 trial.
- The higher dose (0.2%) formulation showed superior efficacy across multiple endpoints, with statistically significant reductions in Eye Dryness Score (-22.8 vs -18.3, p=0.0315) and corneal staining.
- The treatment exhibited a favorable safety profile with only mild to moderate adverse events, positioning IVW-1001 for advancement to pivotal trials.last yeariView Therapeutics Completes Enrollment in Phase 1/2 Trial of IVW-1001 for Dry Eye Disease- iView Therapeutics has finished enrolling patients in its Phase 1/2 clinical trial of IVW-1001, an ophthalmic eyelid wipe for treating dry eye disease.
- The trial is a randomized, multicenter, double-masked study assessing the safety, tolerability, and efficacy of IVW-1001 at different doses compared to a placebo.
- IVW-1001 is a novel TRPM8 agonist designed to enhance tear secretion and alleviate pain by targeting the TRPM8 channel on corneal and eyelid sensory neurons.
- Topline data from the Phase 1/2 trial are expected in the first quarter of 2025, potentially offering a new treatment option for dry eye disease.2 years ago