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Study Status: Withdrawn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:

  1. Evaluation of isolated signs and symptoms during treatment, with a record of individual scores for each parameter and observation
  2. 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. ]

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 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