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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

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.

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Acute Drug: MAXINOM® Drug: Maxitrol® Phase 3

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : February 2011
Estimated Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
Drug Information available for: Maxitrol

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%




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Azidus Brasil

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01227863     History of Changes
Other Study ID Numbers: DNPUNI0610
Version 01
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by Azidus Brasil:
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

Additional relevant MeSH terms:
Conjunctivitis
Signs and Symptoms
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Dexamethasone acetate
Dexamethasone
Fluprednisolone
BB 1101
Neomycin
Polymyxins
Polymyxin B
Dexamethasone, neomycin, polymyxin B drug combination
Bacitracin
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents