Clinical Trial: Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Randomized Clinical Trial Of Drug Topics Efficacy Maxinom® (Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate - Lab. Union Chemical) And Maxitrol® (Dexamethasone + Neomycin Sulfate + Po
Brief Summary: 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.
Detailed Summary:
- 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.
Sponsor: Azidus Brasil
Current Primary Outcome: Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment. [ Time Frame: 7 dyas of treatment. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established. [ Time Frame: 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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety.
- Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during treatment. [ Time Frame: 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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety.
Original Secondary Outcome: Same as current
Information By: Azidus Brasil
Dates:
Date Received: October 15, 2010
Date Started: February 2011
Date Completion:
Last Updated: October 22, 2010
Last Verified: October 2010