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

Bacterial Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01227863
• Other study ID #: DNPUNI0610
• Secondary ID: Version 01
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 15, 2010
• Last updated: October 22, 2010
• Start date: February 2011

Study information

• Verified date: October 2010
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute
• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial
• Signs and Symptoms

Intervention

Drug:
• MAXINOM®
Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%
• Maxitrol®
Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%

Locations

Country	Name	City	State
Brazil	LAL Clinica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.	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 days of treatment.	No
Secondary	Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during 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 days of treatment.	No