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 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
- 70
- 试验地点
- 1
- 主要终点
- Conjunctival redness
研究概览
简要总结
In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis 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)
盲法说明
The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency.
Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked.
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 of 0.7 LogMAR or better
- •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 on days of dosing.
干预措施: TL-925 (Drug)
Placebo Arm
Subjects will be dosed in clinic on days of dosing.
干预措施: Placebo (Drug)
结局指标
主要结局
Conjunctival redness
时间窗: 7, 15 and 20 minutes after CAC
Conjunctival redness will be assessed by the investigator at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).
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 4, 5 and 6. Assessments were reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).
次要结局
未报告次要终点