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

NCT ID: NCT01227863

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

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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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.

Conditions

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Bacterial Conjunctivitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test

Dexamethasone + neomycyn + polimixyn B

Group Type EXPERIMENTAL

MAXINOM®

Intervention Type DRUG

Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%

Comparator

Dexamethasone + neomycyn + polimixy B

Group Type ACTIVE_COMPARATOR

Maxitrol®

Intervention Type DRUG

Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%

Interventions

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Maxitrol®

Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%

Intervention Type DRUG

MAXINOM®

Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

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LAL Clínica Pesquisa e Desenvolvimento Ltda

Locations

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LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Facility Contacts

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Alexandre Frederico, doctor

Role: primary

[email protected]
55 19 3871-6399

Other Identifiers

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Version 01

Identifier Type: -

Identifier Source: secondary_id

DNPUNI0610

Identifier Type: -

Identifier Source: org_study_id