A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in 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
- 16
- 试验地点
- 1
- 主要终点
- Inflammation Change From Baseline to Day 6
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:
Chronic Allergic Inflammation assessed using confocal microscopy 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 4 days between Visits 3 and 4.
Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 2 weeks
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
Inflammation Change From Baseline to Day 6
时间窗: 90 minutes post CAC
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
次要结局
- Ocular Itching Change From Baseline to Day 6(7 minutes post-CAC)
- Ocular Redness Change From Baseline to Day 6(7 minutes post-CAC)