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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | tobramycin 0.3% + dexamethasone 1% - União Química Lab |
|
| Comparator | Active Comparator | tobramycin 0.3% + dexamethasone 1% - Alcon Lab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobracort | Drug | tobramycin 0.3% + dexamethasone 1% |
| |
| Tobradex |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness compared between drugs using the 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 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. | 7 days 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 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. |
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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 of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clínica Pesquisa e Desenvolvimento Ltda | Valinhos | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D000078162 | Tobramycin, Dexamethasone Drug Combination |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Drug |
tobramycin 0.3% + dexamethasone 1% |
|
| 7 days of treatment. |
| Statistical comparison of drug safety, by recording qualitative and quantitative parameters 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 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. | 7 days of treatment. |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D014031 | Tobramycin |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |