A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Bulbar Conjunctival Injection
研究概览
简要总结
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
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
- Single (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
- •Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.
排除标准
- •Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
- •Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit
- •Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
- •Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
研究组 & 干预措施
Alrex
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
干预措施: Loteprednol etabonate 0.2% (Drug)
Patanol
Ophthalmic solution containing olopatadine, 0.1%
干预措施: Olopatadine 0.1% (Drug)
结局指标
主要结局
Bulbar Conjunctival Injection
时间窗: Change from baseline to day 15 (visit 3)
Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Ocular Itching
时间窗: Change from baseline to day 15 (visit 3)
Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe
次要结局
- Bulbar Conjunctival Injection(Change from baseline to day 8 (visit 2))
- Ocular Itching(Change from baseline to day 8 (visit 2))