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This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post Operative Inflammation and Infection in LASIK surgery.
antibiotic/steroid combination compared to individuals components 15 days of treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moxifloxacin/prednisolone combination | Experimental | 1 gtt, 4x/day, 15 days |
|
| moxifloxacin 0,5% + Prednisolone 1% | Active Comparator | 1 drop of each bottle, BID, 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin 0,5% + prednisolone 1% | Drug | 1 gtt, 4x/day, 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Day 15 Evaluation of Anterior Chamber | The primary efficacy variable of this study is the percentage of patients with a score of zero postoperative inflammation (anterior chamber inflammation, ie, presence of cells in the anterior chamber (0-4) in the study on Day 15. The absence of bacterial infection on Day 15 ± 1 will be assumed to demonstrate that the antibacterial agents in the association of moxifloxacin / acetate Prednisolona1% and moxifloxacin + acetate Prednisolona1% Eye drops are equal in antimicrobial effectiveness, and that they acted in a prophylactic manner to prevent of bacterial infection. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| day 15 physician´s follow-up impression of inflammatory reaction score | the clinical evaluation will be based on the following variables: IOP, assessment of visual acuity, slit lamp examination (lids, conjunctiva, cornea), and examination of the fundus (retina / macula / choroid, vitreous and optic nerve). | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rubens Belfort, investigator | Contact | 5511 5572-6443 | prof.belfort@clinicabelfort.com.br | |
| Cristina Mucioli, coordinator | Contact | 55115572-6443 | crissmucci@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Mucioli, Dra. | Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP | São Paulo | SP/Brazil | 4562-020 | Brazil |
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| ID | Term |
|---|---|
| D015817 | Eye Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| moxifloxacin/prednisolone combination | Drug | 1 gtt, 4x/day, 15 days |
|
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |