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

Sponsor

Azidus Brasil (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01227863

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Conjunctivitis Acute	Drug: MAXINOM® Drug: Maxitrol®	Phase 3

Detailed Description

Evaluation of isolated signs and symptoms during treatment, with a record of individual scores for each parameter and observation
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Dexamethasone + neomycyn + polimixyn B	Drug: MAXINOM® Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%
Active Comparator: Comparator Dexamethasone + neomycyn + polimixy B	Drug: Maxitrol® Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%

Arm

Intervention/Treatment

Experimental: Test

Dexamethasone + neomycyn + polimixyn B

Drug: MAXINOM®

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

Active Comparator: Comparator

Dexamethasone + neomycyn + polimixy B

Drug: Maxitrol®

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAL Clinica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo	Brazil

Sponsors and Collaborators

Azidus Brasil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01227863

Other Study ID Numbers:

DNPUNI0610
Version 01

First Posted:

Oct 25, 2010

Last Update Posted:

Oct 25, 2010

Last Verified:

Oct 1, 2010

Keywords provided by , ,

SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

Additional relevant MeSH terms:

Conjunctivitis, Bacterial

Conjunctivitis

Dexamethasone, neomycin, polymyxin B drug combination

Study Results

No Results Posted as of Oct 25, 2010