Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 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 evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 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 0.70 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 in 1 out of 3 time points for the initial and re-challenge 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
Loteprednol etabonate base (QD)
Loteprednol etabonate ophthalmic base dosed once/day.
干预措施: Loteprednol etabonate base (QD) (Drug)
Loteprednol etabonate base (BID)
Loteprednol etabonate ophthalmic base dosed two times/day
干预措施: Loteprednol etabonate base (BID) (Drug)
Loteprednol etabonate base (QID)
Loteprednol etabonate ophthalmic base dosed four times/day.
干预措施: Loteprednol etabonate base (QID) (Drug)
Loteprednol etabonate suspension (QID)
Loteprednol etabonate ophthalmic suspension dosed four times/day
干预措施: Loteprednol etabonate suspension (Drug)
Vehicle of loteprednol etabonate
Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
干预措施: Vehicle of loteprednol etabonate (Drug)
结局指标
主要结局
Ocular Itching
时间窗: Visit 4 (8 hr re-challenge)
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Conjunctival Redness
时间窗: Visit 4 (8 hr re-challenge)
Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.
次要结局
- Ocular Itching(Visit 4 (initial challenge))
- Conjunctival Redness(Visit 4 (initial challenge))