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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bacterial Conjunctivitis, Acute

Intervention / Treatment
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* Drug: MAXINOM®
* Drug: Maxitrol®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS