A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Ocular Itching Change From Baseline to Day 11
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,
Prednisolone, assessed by the following measures:
- Ocular itching
- Conjunctival redness
详细描述
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.
- Prednisolone phosphate
- Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 19 days
Controls:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 18 years of age & either sex, any race
- •Willing and able to follow all instructions
- •Positive history of ocular allergies
- •Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
排除标准
- •Have planned surgery during trial period
- •Female currently pregnant, planning a pregnancy or lactating
- •Use of disallowed medications
- •Have ocular infections, or ocular conditions that could affect study parameters
- •Have moderate to severe dry eye
- •Have used an investigational drug or device within 30 days of start of study
- •Female that is currently pregnant, planning a pregnancy or lactating
研究组 & 干预措施
Prednisolone
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
干预措施: Prednisolone Sodium Phosphate Ophthalmic Solution 1% (Drug)
Placebo
Tears Naturale II Ophthalmic Solution, 1%
干预措施: Tears Naturale II Ophthalmic Solution (Drug)
结局指标
主要结局
Ocular Itching Change From Baseline to Day 11
时间窗: 5 minutes post-CAC
Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
次要结局
- Episcleral Redness Change From Baseline to Day 6(7 minutes post-CAC)
- Ciliary Redness Change From Baseline to Day 6(7 minutes post-CAC)
- Conjunctival Redness Change From Baseline to Day 11(7 Minutes post-CAC)