Efficacy of epinastine hydrochloride ophthalmic solution in the patients with perennial allergic conjunctivitis after treating with olopatadine hydrochloride ophthalmic solution. - Efficacy of epinastine hydrochloride ophthalmic solution in the patients with perennial allergic conjunctivitis.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
[Subjects] - Fifteen patients diagnosed as perennial allergic conjunctives insufficiently controlled with olopatadine hydrochloride ophthalmic solution. (Patients with moderate or severe ocular pruritus after treated with Patanol). Study Period is 4 weeks , from September 1, 2014 to October 31, 2015 (exclude SAC) [Observations] -Subjective symptom and objective finding scores and improvement rate of itching score.IMPROVE when the score at W4 is lower than that of study initiation, WORSEN when the score increases, NONE when there is no change. -Questionnaire after 4weeks : feeling in using the drug and satisfaction level, etc. [Result] The itching score was significantly improved after the treatment was changed from olopatadine hydrochloride ophthalmic solution to epinastine hydrochloride ophthalmic solution. Before the treatment change: 2.5 plus or minus 0.5, 4 weeks after the treatment change: 0.9 plus or minus 0.7(P=0.0004) . Regarding subjective itching symptom, 81.8% of 11 patients were IMPROVE, 18.2% were N0 CHANGE and 0% was GET WORSE. Conjunctival injection score (eyelid + eyeball) was significantly decreased 4 weeks after the treatment was changed. Before the treatment change: 2.3 plus or minus 1.1 , 4 weeks after the treatment change: 1.5 plus or minus 0.7(P=0.0251). The survey on the patients shows satisfaction with the effect on relieving itching, quick acting and a feeling in using the drug. [Conclusion] It was suggested from the study that the changing treatment to epinastine hydrochloride ophthalmic solution with patients diagnosed as perennial allergic conjunctives who were insufficiently controlled with olopatadine hydrochloride ophthalmic solution possibly improved allergic symptoms and was effective on the patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Patients given immunotherapy (hyposensitization therapy, modulated therapy) . 2)Patients with ocular pruritus and hyperemia caused by a disease other than allergic conjunctivitis which will influence drug evaluation. 3)Patients with a history of atopic keratoconjunctivitis, spring catarrh, giant papillary conjunctivitis, corneal herpes, recurrent corneal erosion caused by the frequent occurrence of corneal injury or dry eye. 4)Patients with surgical history in the internal eye (including laser therapy) within 90 days prior to initiation of the clinical research. 5)Patients with possibility taking medicines (including anti-allergic agent, immunosuppressive drugs and adrenal cortex steroid except eye drops) which affect the efficacy of study drug. However, the use of ophthalmic solutions of adrenal cortex steroid is admitted as needed if there is no improvement in symptoms. 6)Females who are or may be pregnant, or lactating 7)Patients with a history of hypersensitivity to study drug 8)Patients with severe complications (such as immediate hospitalized care is required) which are identified inappropriate for safety reason. 9)Patients who have any other reasons that causes the study doctor to deem a subject unsuitable for the study.