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

Azidus

Status and phase: Unknown; Phase 3

Conditions: Acute; Bacterial Conjunctivitis

Treatments: Drug: MAXINOM®; Drug: Maxitrol®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227863

DNPUNI0610

Version 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Test

Experimental group

Description:

Dexamethasone + neomycyn + polimixyn B

Treatment:

Drug: MAXINOM®

Comparator

Active Comparator group

Description:

Dexamethasone + neomycyn + polimixy B

Treatment:

Drug: Maxitrol®