Bacterial Conjunctivitis, Acute
Conditions
Keywords
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
Brief summary
The primary objective of this study is to evaluate, through clinical parameters, the effectiveness of your medicine topic Maxinom ® (dexamethasone, neomycin and polymyxin B - Union Chemicals), comparing it to the topical medication Maxitrol ® (dexamethasone, neomycin and polymyxin B - Alcon ) by the percentage of improvement (sustained response rate) at the end of treatment, among the products studied.
Detailed description
1. Evaluation of isolated signs and symptoms during treatment, with a record of individual scores for each parameter and observation 2. Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
Interventions
DRUGMAXINOM®
Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%
DRUGMaxitrol®
Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%
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, picture of acute bacterial conjunctivitis diagnosed clinically.
Exclusion criteria
* Patients with clinical diagnosis or suspicion of conjunctivitis due to any process that is not due to bacterial infection, such as infections by fungi, protozoa, viruses and allergic conjunctivitis; * Patients with known hypersensitivity to any component of the formulas of the study drugs; * Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars; * Concomitant use of ocular medication other than the study; * Pregnant or lactating women; * Being or having been treated for any type of conjunctivitis within 15 days and have finished treatment or less than 07 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment. | 7 dyas 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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety. |
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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety. |
| Statical comparison of drug safety by recording qualitative and quantitative parameter 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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety. |
Countries
Brazil
Outcome results
None listed