JPRN-UMIN000013943已完成4 期
Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen - Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
In conclusion, the results of this study suggest that olopatadine 0.1% is more effective than epinastine 0.05% at reducing the symptoms of Japanese cedar pollen-induced allergic conjunctivitis in CAC tests, a short-term efficacy evaluation system. Prospective randomized controlled trials in real-life settings are needed to confirm these results and the efficacy and safety of longer term administration of olopatadine.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.have a history of allergic hypersensitivity or known hypersensitivity to any compound or chemical class related to the drug being studied or its excipients used in this trial 2. have the presence of any ocular condition that, could affect the patients safety or study parameters 3. have a known history of vernal keratoconjunctivitis and/or atopic keratoconjunctivitis; 4. have had ocular surgical intervention within 3 months prior to Visit 1 and/or a history of refractive surgery within 6 months prior to Visit 1;5. have any presence of active ocular infection or preauricular lymphadenopathy, or positive history of an ocular herpetic infection at any time prior to Visit 3; 6. have any uncontrolled systemic disease; 7. have a history of status asthmaticus, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to study allergen(s);8. manifest signs or symptoms of clinically active allergic conjunctivitis in either eye; 9. be a female who is currently pregnant, nursing, or planning a pregnancy; 10. use any of the disallowed medications during the study period; aspirin containing products: discontinue 72 hours; H1-antagonist antihistamines and all other anti-allergy therapies : discontinue 72 hours ; all other topical ophthalmic preparations other than study drops : discontinue 72 hours; corticosteroids or mast cell stabalizers: discontinue 14 days; depot corticosteroids: discontinue 6 months 11. have a planned surgery during the trial period or within 30 days after completion; 12. have current enrollment in an investigational drug or device study or administration of investigational drug in such a study within 30 days of entry into this study; 13.have a condition or be in a situation in the investigators opinion that may put the patient at significant risk,may confound the study results, or may interfere significantly with the patients participation in the study.
研究者
相似试验
已完成
3 期
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese SubjectsAllergic ConjunctivitisNCT00987272Alcon Research267
已完成
4 期
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in JapanAllergic ConjunctivitisNCT02251613Alcon Research50
已完成
4 期
Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric PatientsAllergic ConjunctivitisNCT01109485Alcon Research42
已完成
3 期
Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese SubjectsAllergic ConjunctivitisNCT02322216Alcon Research383
已完成
不适用
Efficacy of epinastine hydrochloride ophthalmic solution in patients with allergic conjunctivitisAllergic conjunctivitisJPRN-UMIN000016313Watanabe eye clinic50