Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
研究概览
简要总结
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent).
- •Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
- •Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
- •Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
排除标准
- •Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
- •Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
- •Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
- •Cases with past history of anaphylaxis.
- •Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
- •Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
- •Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
- •Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
研究组 & 干预措施
Olopatadine 0.1% one eye
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
干预措施: Olopatadine 0.1% (Drug)
Tranilast 0.5% one eye
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
干预措施: Tranilast 0.5% (Drug)
Placebo (Olopatadine)
Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye
干预措施: Placebo (Olopatadine) (Drug)
Placebo (Tranilast)
Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
干预措施: Placebo (Tranilast) (Drug)
结局指标
主要结局
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
时间窗: 0-180 minutes after entering the examination room
Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
次要结局
- Change in Total Score in Ocular Symptom Questionnaire(15-180 min.)