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

Study Overview
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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.

Official Title
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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

Conditions
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Acute Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: Tobracort
* Drug: Tobradex


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>tobramycin 0.3% + dexamethasone 1% - União Química Lab | Drug: Tobracort<br>* tobramycin 0.3% + dexamethasone 1%<br>|
| Active Comparator: Comparator<br>tobramycin 0.3% + dexamethasone 1% - Alcon Lab | Drug: Tobradex<br>* tobramycin 0.3% + dexamethasone 1%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days of treatment. | 
| 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. | 7 days of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS