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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01227863
First received: October 15, 2010
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacterial Conjunctivitis
Acute
 Drug: MAXINOM®
Drug: Maxitrol®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment. [ Time Frame: 7 dyas of treatment. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established. [ Time Frame: 7 days of treatment. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227863

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico, doctor     55 19 3871-6399     alexandre@lalclinica.com.br    
Principal Investigator: Jose Roberto de Camargo, doctor            
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01227863     History of Changes
Other Study ID Numbers: DNPUNI0610, Version 01
Study First Received: October 15, 2010
Last Updated: October 22, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

Additional relevant MeSH terms:
Eye Infections, Bacterial
Eye Infections
Conjunctivitis
Conjunctivitis, Bacterial
Signs and Symptoms
Conjunctival Diseases
Eye Diseases
Bacterial Infections
Infection
Polymyxin B
Neomycin
Bacitracin
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Dexamethasone, neomycin, polymyxin B drug combination
Dexamethasone acetate
 Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on June 17, 2013