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Management decision
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The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIGADEXA Gel | Experimental | VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. |
|
| VIGADEXA Solution | Active Comparator | VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel) | Drug | One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative |
| Percentage of patients with no clinically evidenced bacterial infection | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Cells in the anterior chamber (study eye) | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative |
| Ocular pain (study eye) | As assessed by the investigator during patient interview. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| C004180 | dexamethasone 21-phosphate |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution) | Drug | One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery. |
|
|
| Day 15 post-operative |
| Inflammatory reaction (study eye) | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |