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

NCT01227863 | Unknown Phase 3

• 2 other identifiers: DNPUNI0610Version 01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Conjunctivitis; Acute

Keywords

SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  7 days of treatment.

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

  7 days of treatment.

Study Arms (2)

Test

EXPERIMENTAL

Dexamethasone + neomycyn + polimixyn B

Drug: MAXINOM®

Comparator

ACTIVE COMPARATOR

Dexamethasone + neomycyn + polimixy B

Drug: Maxitrol®

Interventions

MAXINOM® DRUG

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

Test

Maxitrol® DRUG

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

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Maxitrol

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 25, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2011
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

BR (1)