Back to resultsEfficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
Primary Purpose
Bacterial Conjunctivitis, Acute
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
MAXINOM®
Maxitrol®
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
Eligibility 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
Sites / Locations
- LAL Clinica Pesquisa e Desenvolvimento Ltda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test
Comparator
Arm Description
Dexamethasone + neomycyn + polimixyn B
Dexamethasone + neomycyn + polimixy B
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01227863
Brief Title
Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
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 Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Azidus Brasil
4. Oversight
5. Study Description
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
Evaluation of isolated signs and symptoms during treatment, with a record of individual scores for each parameter and observation
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis, Acute
Keywords
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Dexamethasone + neomycyn + polimixyn B
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Dexamethasone + neomycyn + polimixy B
Intervention Type
Drug
Intervention Name(s)
MAXINOM®
Intervention Description
Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%
Intervention Type
Drug
Intervention Name(s)
Maxitrol®
Intervention Description
Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%
Primary Outcome Measure Information:
Title
Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment.
Description
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.
Time Frame
7 dyas of treatment.
Secondary Outcome Measure Information:
Title
Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.
Description
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.
Time Frame
7 days of treatment.
Title
Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during treatment.
Description
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.
Time Frame
7 days of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
LAL Clinica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Frederico, doctor
Phone
55 19 3871-6399
Email
alexandre@lalclinica.com.br
First Name & Middle Initial & Last Name & Degree
Jose Roberto de Camargo, doctor
12. IPD Sharing Statement
Learn more about this trial
Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
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