A Single-Center, Double-Masked, Randomized, Vehicle Controlled Evaluation of the Onset and Duration of Action of RX-10045 Ophthalmic Solution, 0.09% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ocular itching
研究概览
简要总结
To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic solution in alleviating the signs and symptoms of allergic conjunctivitis
详细描述
Allergies are relatively common among the general population. Ocular signs and symptoms include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. Allergic reactions can vary from a mild, self-limiting disease, to a debilitating condition that significantly impairs the quality of life of allergen-sensitive individuals.
Currently approved treatments for ocular allergy reduce the signs and symptoms of the early phase reaction; however, evidence suggests that many patients suffer from the persistent late phase reaction. Manifestations of the late phase reaction occur 6 to 24 hours after allergen exposure and are characterized by an influx of acute inflammatory cells into the conjunctivae. Administration of anti-inflammatory agents decreases allergy signs and symptoms in both the early and late phase reactions.
RX-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models and in a pre-clinical model of allergic conjunctivitis. The objective of this clinical study is to assess the safety and efficacy of RX-10045 ophthalmic solution for the treatment of the signs and symptoms of allergic conjunctivitis induced in the Conjunctival Allergen Challenge Model of allergic conjunctivitis at 15 minutes and 8 hours after medication instillation. It is anticipated that RX-10045 has therapeutic potential for the treatment of allergic conjunctivitis and an acceptable risk-benefit profile.
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
- •Subjects MUST:
- •Have a positive history of ocular allergies
- •Have a positive bilateral conjunctival allergen challenge (CAC) reaction
排除标准
- •Subjects MUST NOT:
- •Have known contraindications or sensitivities to study medication or its components
- •Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- •Use a disallowed medication during the period indicated prior to the enrollment or during the study
- •Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
研究组 & 干预措施
RX-10045 active arm
RX-10045 Ophthalmic Solution, 0.09%
干预措施: RX-10045 (Drug)
Vehicle for RX-10045 arm
Vehicle of RX-10045 Ophthalmic Solution
干预措施: Vehicle for RX-10045 arm (Drug)
结局指标
主要结局
Ocular itching
时间窗: Baseline to day 14
Ocular itching at defined timepoints up to 2 weeks
Conjunctival redness
时间窗: Baseline to day 14
Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks
次要结局
- Eyelid swelling(Baseline to day 14)
- Ciliary and episcleral redness(Baseline to day 14)
- Chemosis(Baseline to day 14)
- Tearing(Baseline to day 14)