Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 847
- 主要终点
- Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale
研究概览
简要总结
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.
排除标准
- 未提供
研究组 & 干预措施
Relestat Ophthalmic Solution 0.05%
Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
干预措施: Relestat Ophthalmic Solution 0.05% (Drug)
结局指标
主要结局
Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale
时间窗: Baseline, 2 Weeks
Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.
Percentage of Patients Reporting Adverse Events
时间窗: Up to 10 Months
An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
次要结局
未报告次要终点