Clinical trial NCT01227863: Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Acute
Keywords: SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment.
timeFrame: 7 dyas of treatment.
Secondary outcomes:
measure: Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.
timeFrame: 7 days of treatment.
measure: Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during treatment.
timeFrame: 7 days of treatment.
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica Pesquisa e Desenvolvimento Ltda
state: São Paulo
Study officials:
References: