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

Primary Purpose

Acute Bacterial Conjunctivitis

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Tobracort
Tobradex
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Conjunctivitis focused on measuring SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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, 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

Sites / Locations

  • LAL Clínica Pesquisa e Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test

Comparator

Arm Description

tobramycin 0.3% + dexamethasone 1% - União Química Lab

tobramycin 0.3% + dexamethasone 1% - Alcon Lab

Outcomes

Primary Outcome Measures

Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end 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

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

Full Information

First Posted
October 15, 2010
Last Updated
October 22, 2010
Sponsor
Azidus Brasil
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1. Study Identification

Unique Protocol Identification Number
NCT01227915
Brief Title
Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis
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 Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Azidus Brasil

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Conjunctivitis
Keywords
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
tobramycin 0.3% + dexamethasone 1% - União Química Lab
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
tobramycin 0.3% + dexamethasone 1% - Alcon Lab
Intervention Type
Drug
Intervention Name(s)
Tobracort
Intervention Description
tobramycin 0.3% + dexamethasone 1%
Intervention Type
Drug
Intervention Name(s)
Tobradex
Intervention Description
tobramycin 0.3% + dexamethasone 1%
Primary Outcome Measure Information:
Title
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
Description
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.
Time Frame
7 days of treatment
Secondary Outcome Measure Information:
Title
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.
Description
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.
Time Frame
7 days of treatment.
Title
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
Description
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.
Time Frame
7 days of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, 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
Facility Information:
Facility Name
LAL Clínica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Frederico, doctor
Phone
55 19 3871-6399
Email
alexandre@lalclinica.com.br
First Name & Middle Initial & Last Name & Degree
Jose Roberto de Camargo, doctor

12. IPD Sharing Statement

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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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