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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bacterial Conjunctivitis; Acute
• Intervention / Treatment: Drug: MAXINOM®; Drug: Maxitrol®

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: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil
      • LAL Clínica Pesquisa e Desenvolvimento Ltda
      • Contact: Alexandre Frederico, doctor; Phone Number: 55 19 3871-6399; Email: alexandre@lalclinica.com.br
      • Principal Investigator: Jose Roberto de Camargo, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Dexamethasone + neomycyn + polimixyn B	Drug: MAXINOM®; Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%
Active Comparator: Comparator; Dexamethasone + neomycyn + polimixy B	Drug: Maxitrol®; Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end 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.	7 dyas of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.	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.	7 days of treatment.
Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during 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.	7 days of treatment.

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Dexamethasone, neomycin, polymyxin B drug combination
• Other Study ID Numbers: DNPUNI0610; Version 01