A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) 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
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Ocular Itching
研究概览
简要总结
To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms 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
- Triple (Participant, Care Provider, Investigator)
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
- •be at least 18 years old
- •be willing and able to avoid all disallowed medications and contact lenses
- •must have a pregnancy test if of childbearing potential
- •must be able to read an eye chart from 10 feet away
排除标准
- •must not have any allergies to the study medications
- •must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
- •must not have used immunotherapy in the last 2 years
- •must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
研究组 & 干预措施
Bilastine 0.2%
Bilastine Ophthalmic solution 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
干预措施: Bilastine 0.2% (Drug)
Bilastine 0.4%
Bilastine Ophthalmic solution 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
干预措施: Bilastine 0.4% (Drug)
Bilastine 0.6%
Bilastine Ophthalmic solution 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
干预措施: Bilastine 0.6% (Drug)
Bilastine 0%
Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 3 separate times during a 25 day period.
干预措施: Bilastine 0% (Drug)
结局指标
主要结局
Ocular Itching
时间窗: The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).
The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.
次要结局
未报告次要终点