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

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ClinicalTrials.gov Identifier: NCT01227915
Recruitment Status : Unknown
Verified October 2010 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Sponsor:
Information provided by:
Azidus Brasil

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Bacterial Conjunctivitis Drug: Tobracort Drug: Tobradex Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : February 2011
Estimated Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test
tobramycin 0.3% + dexamethasone 1% - União Química Lab
Drug: Tobracort
tobramycin 0.3% + dexamethasone 1%
Active Comparator: Comparator
tobramycin 0.3% + dexamethasone 1% - Alcon Lab
Drug: Tobradex
tobramycin 0.3% + dexamethasone 1%



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227915


Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico, doctor    55 19 3871-6399    alexandre@lalclinica.com.br   
Principal Investigator: Jose Roberto de Camargo, doctor         
Sponsors and Collaborators
Azidus Brasil

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01227915     History of Changes
Other Study ID Numbers: TODUNI0610
Version 01
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by Azidus Brasil:
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

Additional relevant MeSH terms:
Conjunctivitis
Signs and Symptoms
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Dexamethasone acetate
Dexamethasone
BB 1101
Tobramycin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents