A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Ocular Itching
研究概览
简要总结
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced 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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
- •Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
- •Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit
- •Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.
排除标准
- •Known contraindications or sensitivities to the study medication or its components.
- •Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
- •Use of disallowed medications during the period indicated prior to study enrollment or during the study.
研究组 & 干预措施
Ketotifen/naphazoline
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
干预措施: Ketotifen/naphazoline (Drug)
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
干预措施: Vehicle (Drug)
Naphazoline
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
干预措施: Naphazoline (Drug)
Ketotifen
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
干预措施: Ketotifen (Drug)
结局指标
主要结局
Ocular Itching
时间窗: 3, 5, and 7 minutes post challenge at 14 days
Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub
Conjunctival Redness
时间窗: 7, 15, and 20 minutes post challenge at 14 days
Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.
次要结局
- Episcleral Redness(7, 15, and 20 minutes post challenge at 14 days)
- Chemosis(7, 15, and 20 minutes post challenge at 14 days)
- Eyelid Swelling(7, 15, and 20 minutes post challenge at 14 days)
- Percentage of Eyes With Ocular Mucus Discharge(7, 15, and 20 minutes post challenge at 14 days)
- Ciliary Redness(7, 15, and 20 minutes post challenge at 14 days)
- Percentage of Eyes With hTearing(7, 15, and 20 minutes post challenge at 14 days)