Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Treatment of Acute Viral Conjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in ocular symptoms from baseline to treatment day 7
研究概览
简要总结
The purpose of this study is to evaluate the evolution of the symptoms of acute viral conjunctivitis using preservative free ketorolac trometamol 0.45% associated with carboxymethylcellulose compared with isolated use of preservative-free artificial tears.
详细描述
The purpose of this study is to evaluate the evolution of the symptoms of acute viral conjunctivitis using preservative free ketorolac trometamol 0.45% associated with carboxymethylcellulose compared with isolated use of preservative-free artificial tears. A randomized double-masked study will include 60 patients divided into two groups: Group 1: using a formulation of ketorolac tromethamine 0.45% associated with carboxymethylcellulose (Acular CMC®, Allergan, Irvine, USA) and Group 0: using artificial tears (Optive UD®, Allergan, Irvine, USA), both drugs without preservatives.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute conjunctivitis (unilateral or bilateral) for less than two weeks,
- •Signs and symptoms consistent with viral conjunctivitis and at least one of the following: preauricular lymphadenopathy, upper tract respiratory infection or recent contact with someone with conjunctivitis
排除标准
- •pregnant women
- •allergies to non-steroidal anti-inflammatories
- •history of seasonal allergic conjunctivitis
- •contact lens wearers
- •history of ocular herpes infection
- •blepharitis
- •severe dry eye
- •purulent discharge
- •defects in the corneal epithelium
研究组 & 干预措施
Ketorolac trometamol 0.45%
Ketorolac trometamol 0.45% associated with carboxymethylcellulose eye drops (Acular CMC®, Allergan, Irvine, USA) qid for 7 days.
干预措施: Ketorolac trometamol 0.45% with carboxymethylcellulose (Drug)
Artificial tears
Preservative free artificial tears (Optive UD®, Allergan, Irvine, USA) qid for 7 days.
干预措施: Preservative free artificial tear (Drug)
结局指标
主要结局
Change in ocular symptoms from baseline to treatment day 7
时间窗: 7 days
General ocular discomfort, itching, foreign body sensation, tearing, eye redness and eyelid edema. Symptoms will be graded as 0 (absence), I (mild), II (moderate) and III (severe).
Change in ocular signs from baseline to treatment day 7
时间窗: 7 days
The clinical examination will consist of slit-lamp examination of the anterior segment. Four signs will be assessed: conjunctival hyperemia, chemosis, secretion and follicles in lower tarsal conjunctiva. The signs will be classified as 0 (absence), I (mild), II (moderate), III (severe)
次要结局
未报告次要终点