A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
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
- 否
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 refractive surgery (including LASIK procedures) within the past 2 years
- •History of retinal detachment, diabetic retinopathy, or active retinal disease
- •Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
- •Use any of the disallowed medications during the period indicated
- •History of IOP increase as a result of steroid treatment
研究组 & 干预措施
OTX-DP
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
干预措施: Dexamethasone (Drug)
PV
PV (placebo drug delivery vehicle)
干预措施: Placebo Vehicle (Other)
结局指标
主要结局
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
时间窗: 7 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
时间窗: 5 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
次要结局
未报告次要终点