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| ID | Type | Description | Link |
|---|---|---|---|
| Version 01 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Dexamethasone + neomycyn + polimixyn B |
|
| Comparator | Active Comparator | Dexamethasone + neomycyn + polimixy B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAXINOM® | Drug | Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1% |
| Measure | Description | Time Frame |
|---|---|---|
| Compared effectiveness between drugs using 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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety. | 7 dyas of treatment. |
| 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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety. |
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Inclusion Criteria:
Patients who agree with all study procedures and sign, by his own free will, IC;
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;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clinica Pesquisa e Desenvolvimento Ltda | Valinhos | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C049064 | Maxitrol |
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| Maxitrol® | Drug | Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1% |
|
| 7 days of treatment. |
| Statical comparison of drug safety by recording qualitative and quantitative parameter 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 7 day, the tolerance will be +- 1 day. On each return will be collected data on the efficacy and safety. | 7 days of treatment. |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |