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Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT01227863
Recruitment Status : Unknown
Verified October 2010 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Sponsor:
Information provided by:
Azidus Brasil

Tracking Information
First Submitted Date  ICMJE October 15, 2010
First Posted Date  ICMJE October 25, 2010
Last Update Posted Date October 25, 2010
Study Start Date  ICMJE February 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
Official Title  ICMJE 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
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 Description
  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Conjunctivitis
  • Acute
Intervention  ICMJE
  • Drug: MAXINOM®
    Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%
  • Drug: Maxitrol®
    Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%
Study Arms  ICMJE
  • Experimental: Test
    Dexamethasone + neomycyn + polimixyn B
    Intervention: Drug: MAXINOM®
  • Active Comparator: Comparator
    Dexamethasone + neomycyn + polimixy B
    Intervention: Drug: Maxitrol®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2010)
70
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01227863
Other Study ID Numbers  ICMJE DNPUNI0610
Version 01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azidus Brasil
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP