A Single Center, Randomized, Double-masked, Vehicle Controlled Phase 2 Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Seasonal Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ocular Itching
研究概览
简要总结
In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 60 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.
The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.
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
- •Individuals aged 18 years or older
- •Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
- •Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
- •Calculated best-corrected visual activity
- •Positive bilateral CAC reaction
排除标准
- •Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
- •Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
- •Any ongoing ocular infection (bacterial, viral or fungal)
研究组 & 干预措施
TL-925 Arm
Subjects will be dosed in clinic.
干预措施: TL-925 (Drug)
Placebo Arm
Subjects wil be dosed in clinic.
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Itching
时间窗: 3, 5 and 7 minutes after CAC
Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4d , 5d, and 6c.
Conjunctival Redness
时间窗: 7, 15 and 20 minutes after CAC
Conjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4d, 5d, and 6c.
次要结局
未报告次要终点