NCT01258309已完成3 期
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 129
- 主要终点
- Ocular Itching
研究概览
简要总结
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of seasonal allergic conjunctivitis
排除标准
- •Ocular infection or history of ocular herpes infection
- •History of retinal detachment or diabetic retinopathy
- •Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
- •Ocular surgery within 8 weeks
研究组 & 干预措施
1
Experimental
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
干预措施: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution (Drug)
2
Active Comparator
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
干预措施: olopatadine hydrochloride 0.1% ophthalmic solution (Drug)
结局指标
主要结局
Ocular Itching
时间窗: Day 21
次要结局
- Chemosis(Day 21)
- Hyperemia(Day 21)
- Ocular mucous discharge(Day 21)
研究者
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