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
Overview
- Phase
- Phase 3
- Intervention
- Tobracort
- Conditions
- Acute Bacterial Conjunctivitis
- Sponsor
- Azidus Brasil
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Arms & Interventions
Test
tobramycin 0.3% + dexamethasone 1% - União Química Lab
Intervention: Tobracort
Comparator
tobramycin 0.3% + dexamethasone 1% - Alcon Lab
Intervention: Tobradex
Outcomes
Primary Outcomes
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 Outcomes
- Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.(7 days of treatment.)
- Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.(7 days of treatment.)