Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis

Overview

The primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% – Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % – Alcon Lab), using the percentage of improvement (sustained response rate) at the end of treatment.

Full Title of Study: “RANDOMIZED CLINICAL EVALUATION OF EFFECTIVENESS COMPARISON BETWEEN DRUGS OPHTHALMOLOGICAL TOBRACORT® (TOBRAMYCIN + DEXAMETHASONE – LAB. UNIÃO QUÍMICA)AND TOBRADEX® (TOBRAMYCIN + DEXAMETHASONE – LAB. ALCON) IN REDUCING THE SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: February 2011

Detailed Description

- Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter;

- Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

Interventions

  • Drug: Tobracort
    • tobramycin 0.3% + dexamethasone 1%
  • Drug: Tobradex
    • tobramycin 0.3% + dexamethasone 1%

Arms, Groups and Cohorts

  • Experimental: Test
    • tobramycin 0.3% + dexamethasone 1% – União Química Lab
  • Active Comparator: Comparator
    • tobramycin 0.3% + dexamethasone 1% – Alcon Lab

Clinical Trial Outcome Measures

Primary Measures

  • Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
    • Time Frame: 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 seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.

Secondary Measures

  • Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.
    • Time Frame: 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 seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
  • Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
    • Time Frame: 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 seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.

Participating in This Clinical Trial

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, a clinical picture of acute bacterial conjunctivitis diagnosed clinically.

Exclusion Criteria

  • Patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;
  • Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars;
  • Patients with known hypersensitivity to any component of the study drug;
  • Concomitant use of ocular medication other than the study;
  • Patients who have made use of systemic anti-inflammatory hormone in the 30 days preceding inclusion;
  • Patients who have made use of systemic antibiotics in the 15 days preceding inclusion;
  • Pregnant or lactating women;
  • Being or having been treated for any type of conjunctivitis is less than 15 days, or have finished treatment at least 7 days

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azidus Brasil
  • Provider of Information About this Clinical Study
    • Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda

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