Randomized Clinical Trial Of Drug Topics Efficacy Maxinom® (Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate - Lab. Union Chemical) And Maxitrol® (Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate - Lab. Alcon) In Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
试验速览
- 阶段
- 3 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment.
研究概览
简要总结
The primary objective of this study is to evaluate, through clinical parameters, the effectiveness of your medicine topic Maxinom ® (dexamethasone, neomycin and polymyxin B - Union Chemicals), comparing it to the topical medication Maxitrol ® (dexamethasone, neomycin and polymyxin B - Alcon ) by the percentage of improvement (sustained response rate) at the end of treatment, among the products studied.
详细描述
- Evaluation of isolated signs and symptoms during treatment, with a record of individual scores for each parameter and observation
- Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
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
- Single (Investigator)
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
- •Patients who agree with all study procedures and sign, by his own free will, IC;
- •Adult patients, regardless of gender, ethnicity or social status, with good mental health;
- •Patients who present at screening visit, picture of acute bacterial conjunctivitis diagnosed clinically.
排除标准
- •Patients with clinical diagnosis or suspicion of conjunctivitis due to any process that is not due to bacterial infection, such as infections by fungi, protozoa, viruses and allergic conjunctivitis;
- •Patients with known hypersensitivity to any component of the formulas of the study drugs;
- •Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars;
- •Concomitant use of ocular medication other than the study;
- •Pregnant or lactating women;
- •Being or having been treated for any type of conjunctivitis within 15 days and have finished treatment or less than 07 days
研究组 & 干预措施
Test
Dexamethasone + neomycyn + polimixyn B
干预措施: MAXINOM® (Drug)
Comparator
Dexamethasone + neomycyn + polimixy B
干预措施: Maxitrol® (Drug)
结局指标
主要结局
Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment.
时间窗: 7 dyas of treatment.
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment. At the returns of 1 and 3 days there will be a tolerance of + 1 day and the return of 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety.
次要结局
- Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.(7 days of treatment.)
- Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during treatment.(7 days of treatment.)