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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Association | Experimental | 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo |
|
| Isolated ingredients | Active Comparator | 0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% gatifloxacin and 1.0% prednisolone acetate association | Drug | Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the association and another with placebo. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations. This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery. | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo - Dept of Ophthalmology | São Paulo | São Paulo | 04023-062 | Brazil |
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| isolated 0.3% gatifloxacin and 1.0% prednisolone acetate | Drug | Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the 0.3% gatifloxacin eye drops and another with 1.0% prednisolone acetate eye drops. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations. This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15. |
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|
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077734 | Gatifloxacin |
| C009935 | prednisolone acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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