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
Tobracort
+ Tobradex
Treatment Study
Summary
Study start date: February 1, 2011
Actual date on which the first participant was enrolled.* 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, BrazilOpen LAL Clínica Pesquisa e Desenvolvimento Ltda in Google Maps