NCT05715346已完成1 期
A Phase 1/2a Study of LEV102 Topical Gel in Subjects With Acquired Blepharoptosis
Levation Pharma, Ltd.3 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年2月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
研究概览
简要总结
Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.
详细描述
This is a Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, single-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis. Subjects will receive a one-time application of randomized, double-masked IP. Approximately 30 subjects will be enrolled in this study. Eligible subjects will be randomized to 1 of the following 3 treatment groups in a 1:1:1 ratio and will receive a single dose of double-masked IP externally on the upper eyelid of both eyes (OU):
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
- 25 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must:
- •Be male or female subjects 25 years of age or older at the time of Screening (Visit 1)
- •Have complaints of aesthetically unacceptable upper eyelid position for both eyes making them desirous for elevation, or have complaints of superior visual field defects in both eyes that impact activities of daily living
- •Present with the following at Screening (Visit 1):
- •a. At least one eye that meets both of the following criteria: i. Margin Reflex Distance 1 MRD1 ≤2 mm (no visible central pupillary light reflex defaults to 0) ii. Current corrected VA, using subject's own prescription eyeglasses, if applicable, in the qualifying eye(s) of +0.3 LogMAR (Logarithm of the Minimum Angle of Resolution) or better as assessed by ETDRS b. Demonstrate upper eyelid elevation ≥0.5 mm change from baseline in MRD1 in both eyes in response to a single drop of oxymetazoline 0.1% ophthalmic solution)to each eye at Screening
- •Women of Childbearing Potential must agree to use an approved method of birth control from the date they sign the informed consent form (ICF) until after the last study visit (Follow-Up Visit)
- •Be able to give informed consent and willing to comply with all study visits and examinations
排除标准
- •Have any other ocular pathology other than ptosis requiring treatment with topical prescription ophthalmic drops in either eye (e.g., glaucoma, dry eye)
- •Have narrow angles, glaucoma, intraocular pressure >23 mmHg or diagnosis of ocular hypertension, cup-to-disc ratio of >0.7, or history of any glaucoma eye surgery in either eye
- •Have any active ocular or peri-ocular infection; any history of recurrent or chronic infection or inflammation in either eye
- •Have a history of allergic reaction to the investigational drug or any of its components
- •Within 7 days of Screening (Visit 1), or anticipated use during the study, use of any systemic, intranasal, topical dermatologic, or ophthalmic α-adrenergic agonist (including brimonidine) or antagonist including nasal or ocular or oral decongestants including pseudoephedrine, oxymetazoline topical ophthalmic solution, oxymetazoline topical dermatologic cream
- •Subjects who are pregnant or breast-feeding
研究组 & 干预措施
LEV102 Topical Gel, 2.0%
Experimental
干预措施: LEV102 2.0% (Drug)
LEV102 Topical Gel, 1.0%
Experimental
干预措施: LEV102 1.0% (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
时间窗: Day 2-5
Adverse events
次要结局
- Upper Eyelid Height(Day 1)
研究者
研究点 (3)
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