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

Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Conjunctivitis; Acute

Intervention: MAXINOM® (Drug); Maxitrol® (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment.

Secondary outcome:

Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.

Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during treatment.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

LAL Clinica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo, Brazil; Not yet recruiting
Alexandre Frederico, doctor, Phone: 55 19 3871-6399, Email: alexandre@lalclinica.com.br
Jose Roberto de Camargo, doctor, Principal Investigator
Additional Information

Starting date: February 2011
Last updated: October 22, 2010

Page last updated: August 23, 2015

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