RANDOMIZED CLINICAL EVALUATION OF EFFECTIVENESS COMPARISON BETWEEN DRUGS OPHTHALMOLOGICAL TOBRACORT® (TOBRAMYCIN + DEXAMETHASONE - LAB. UNIÃO QUÍMICA)AND TOBRADEX® (TOBRAMYCIN + DEXAMETHASONE - 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
- Effectiveness compared between drugs using the 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 comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% - Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using the percentage of improvement (sustained response rate) at the end of treatment.
详细描述
- Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter;
- Observation and 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, a clinical picture of acute bacterial conjunctivitis diagnosed clinically.
排除标准
- •Patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;
- •Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars;
- •Patients with known hypersensitivity to any component of the study drug;
- •Concomitant use of ocular medication other than the study;
- •Patients who have made use of systemic anti-inflammatory hormone in the 30 days preceding inclusion;
- •Patients who have made use of systemic antibiotics in the 15 days preceding inclusion;
- •Pregnant or lactating women;
- •Being or having been treated for any type of conjunctivitis is less than 15 days, or have finished treatment at least 7 days
研究组 & 干预措施
Test
tobramycin 0.3% + dexamethasone 1% - União Química Lab
干预措施: Tobracort (Drug)
Comparator
tobramycin 0.3% + dexamethasone 1% - Alcon Lab
干预措施: Tobradex (Drug)
结局指标
主要结局
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
时间窗: 7 days 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 seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
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.)
- Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.(7 days of treatment.)