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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: February 2011

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.

Interventions

  • Drug: MAXINOM®
    • Dexamethasone………………………………………..0,1% Neomicyn………………………………..0,35% polimixyn B……………………………..0,1%
  • Drug: Maxitrol®
    • Dexamethasone………………………………………..0,1% Neomicyn………………………………..0,35% Polimixyn B……………………………..0,1%

Arms, Groups and Cohorts

  • Experimental: Test
    • Dexamethasone + neomycyn + polimixyn B
  • Active Comparator: Comparator
    • Dexamethasone + neomycyn + polimixy B

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azidus Brasil
  • Provider of Information About this Clinical Study
    • Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.