JPRN-jRCT2080223524已完成3 期
Double-masked, Comparison Study of DE-114A Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
研究概览
简要总结
The superiority of DE-114A ophthalmic solution (equivalent to 2 times a day) to placebo ophthalmic solution and non-inferiority to 0.05% epinastine hydrochloride ophthalmic solution (equivalent to 4 times a day) were verified. No adverse drug reaction and no safety issues were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •Provided signed, written informed consent.
- •Has a positive result from an allergen-specific IgE antibody test.
排除标准
- •Eye disease other than allergic conjunctivitis is present and requires treatment.
- •Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
研究者
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