NCT01109485已完成4 期
Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose parents or guardians can issue informed consent
- •Patients aged over 7 and less than 16 at the baseline
- •Patients confirmed to show type I allergy
- •Patients with allergic conjunctivitis
- •Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)
排除标准
- •Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis
- •Patients having retinal detachment, diabetic retinopathy or progressive retinal disease
- •Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury
- •Patients having received continuous treatment with corticosteroid within 3 months
- •Patients having received immunotherapy
- •Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
- •Patients having undergone ocular laser therapy within 3 months
- •Unilaterally blind patients (best corrected visual acuity: below 0.01)
- •Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
- •Patients necessitating the use of contact lens during the study period
- •Other patients judged by the attending physician as inappropriate for study
研究组 & 干预措施
Olopatadine
Experimental
Olopatadine hydrochloride ophthalmic solution 0.1%
干预措施: Olopatadine hydrochloride ophthalmic solution 0.1% (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 4 weeks
Questionnaire about compliance with dosing instructions
时间窗: 4 weeks
(1;always \>90% 2;often 75-90% 3;sometimes 50-75% 4;seldom \<50%)
次要结局
- Changes in score of subjective symptoms and objective findings(4 weeks)
- Questionnaire about stinging after instillation(4 weeks)
研究者
研究点 (1)
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