Acute Bacterial Conjunctivitis
Conditions
Keywords
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
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.
Interventions
DRUGTobracort
tobramycin 0.3% + dexamethasone 1%
DRUGTobradex
tobramycin 0.3% + dexamethasone 1%
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established. | 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. |
| Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment. | 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. |
Countries
Brazil
Outcome results
None listed