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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01227915
First received: October 15, 2010
Last updated: October 22, 2010
Last verified: October 2010

October 15, 2010
October 22, 2010
February 2011
February 2011   (final data collection date for primary outcome measure)
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment. [ Time Frame: 7 days of treatment ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01227915 on ClinicalTrials.gov Archive Site
  • Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established. [ Time Frame: 7 days of treatment. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis
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

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.

  • 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Acute Bacterial Conjunctivitis
  • Drug: Tobracort
    tobramycin 0.3% + dexamethasone 1%
  • Drug: Tobradex
    tobramycin 0.3% + dexamethasone 1%
  • Experimental: Test
    tobramycin 0.3% + dexamethasone 1% - União Química Lab
    Intervention: Drug: Tobracort
  • Active Comparator: Comparator
    tobramycin 0.3% + dexamethasone 1% - Alcon Lab
    Intervention: Drug: Tobradex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
Not Provided
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Brazil
 
NCT01227915
TODUNI0610, Version 01
Not Provided
Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP