NCT05372107已完成1 期
A Multicenter, Double-Masked, Phase 1b Study Evaluating the Safety, Tolerability, and Dose-Response of Topical AG-80308 in Patients 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
- 84
- 试验地点
- 3
- 主要终点
- Evaluation of adverse events (AEs) and serious AEs (SAEs)
研究概览
简要总结
This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.
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)
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
- •Male or female, 18 years of age or older at the screening visit
- •Diagnosis of dry eye disease in both eyes with or without meibomian gland disease
排除标准
- •Participation in any investigational study within 30 days prior to baseline or exposure to an investigational drug must be fully washed out (at least 5 half-lives)
- •Any ocular infection or inflammation within 30 days prior to the screening visit
- •Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis)
- •History of chronic ocular allergy, systemic lupus erythematosus, rheumatoid arthritis, corneal ulcer/erosions, uveitis or dry eye due to Stevens Johnson syndrome, irradiation, alkali burns, cicatricial pemphigoid or vitamin A deficiency.
- •Use of contact lenses in either eye within 14 days of screening visit or planned use during the study
- •Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit
研究组 & 干预措施
Group 1
Experimental
One drop of 0.001% AG-80308, two times daily to both eyes for 3 months
干预措施: AG-80308 (Drug)
Group 2
Experimental
One drop of 0.03% AG-80308, two times daily to both eyes for 3 months
干预措施: AG-80308 (Drug)
Group 3
Experimental
One drop of 0.1% AG-80308, two times daily to both eyes for 3 months
干预措施: AG-80308 (Drug)
Group 4
Experimental
One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months
干预措施: AG-80308 (Drug)
结局指标
主要结局
Evaluation of adverse events (AEs) and serious AEs (SAEs)
时间窗: Screening to 3 months
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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