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

NCT ID: NCT01227915

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Brief Summary

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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

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* 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.

Conditions

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Acute Bacterial Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test

tobramycin 0.3% + dexamethasone 1% - União Química Lab

Group Type EXPERIMENTAL

Tobracort

Intervention Type DRUG

tobramycin 0.3% + dexamethasone 1%

Comparator

tobramycin 0.3% + dexamethasone 1% - Alcon Lab

Group Type ACTIVE_COMPARATOR

Tobradex

Intervention Type DRUG

tobramycin 0.3% + dexamethasone 1%

Interventions

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Tobracort

tobramycin 0.3% + dexamethasone 1%

Intervention Type DRUG

Tobradex

tobramycin 0.3% + dexamethasone 1%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azidus Brasil

INDUSTRY

Sponsor Role lead

Responsible Party

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LAL Clínica Pesquisa e Desenvolvimento Ltda

Locations

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LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Facility Contacts

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Alexandre Frederico, doctor

Role: primary

[email protected]
55 19 3871-6399

Other Identifiers

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Version 01

Identifier Type: -

Identifier Source: secondary_id

TODUNI0610

Identifier Type: -

Identifier Source: org_study_id