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

Phase 3

• Conditions: Bacterial Conjunctivitis; Acute
• Interventions: Drug: MAXINOM®; Drug: Maxitrol®

• Registration Number: NCT01227863
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2010-10
• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-22
• Last Update Submitted: 2010-10-22
• Study First Posted: 2010-10-25
• Last Update Posted: 2010-10-25
• Study Start: 2011-02
• Primary Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	MAXINOM®	Dexamethasone + neomycyn + polimixyn B
Comparator	Maxitrol®	Dexamethasone + neomycyn + polimixy B

Primary Outcome Measures

Name	Time	Method
Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment.	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

Name	Time	Method
Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.	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.
Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during treatment.	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.

Trial Locations

Locations (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda; 🇧🇷 Valinhos, São Paulo, Brazil