Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Mean Ocular Itching Score Compared to Placebo Period1
研究概览
简要总结
The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided signed, written informed consent.
- •Has a positive result from an allergen-specific IgE antibody test.
- •If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
排除标准
- •Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- •Presence of any abnormality or significant illness that could be expected to interfere with the study.
研究组 & 干预措施
1
干预措施: DE-114 ophthalmic solution (Drug)
2
干预措施: Placebo ophthalmic solution (Drug)
3
干预措施: Olopatadine Hydrochloride 0.1% Ophthalmic Solution (Drug)
结局指标
主要结局
Mean Ocular Itching Score Compared to Placebo Period1
时间窗: Visit 5 (3, 5, and 10 minutes post-CAC)
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .
Mean Hyperemia Score Compared to Placebo Period1
时间窗: Visit 5 (5, 10, and 20 minutes post-CAC)
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .
次要结局
- Mean Hyperemia Score Compared to Olopatadine Period2(Visit 7 (5, 10, and 20 minutes post-CAC))
- Mean Ocular Itching Score Compared to Olopatadine Period2(Visit 7 (3, 5, and 10 minutes post-CAC))