NCT02062905已完成2 期
A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 2 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Ocular Itching
研究概览
简要总结
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic 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
- Double (Participant, 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
- 是
入选标准
- •Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
- •Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation
排除标准
- •History of ocular surgical intervention within the past 3 months
- •Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
- •Use any of the following disallowed medications during the period indicated
研究组 & 干预措施
OTX-DP
Experimental
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
干预措施: Dexamethasone (Drug)
PV
Placebo Comparator
PV (placebo drug delivery vehicle)
干预措施: Placebo Vehicle (Other)
结局指标
主要结局
Ocular Itching
时间窗: 14 days post insertion
Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
次要结局
- Conjunctival Redness(14 days post insertion)
研究者
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