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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002647-35 |
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To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nepafenac | Experimental | One drop in the study eye 3 times daily for 23 days |
|
| Ketorolac Trometamol | Active Comparator | One drop in the study eye 3 times daily for 23 days |
|
| Nepafenac Vehicle | Placebo Comparator | One drop in the study eye 3 times daily for 23 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac 1mg/ml eye drops, suspension | Drug | One drop in the study eye 3 times daily for 23 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients with Day 14 Cure | Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14. | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19668532 | Result | Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33. |
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| Ketorolac Trometamol 5 mg/ml eye drops, solution | Drug | One drop in the study eye 3 times daily for 23 days |
|
| Nepafenac vehicle eye drops | Other | One drop in the study eye 3 times daily for 23 days |
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| D009883 | Ophthalmic Solutions |
| D013535 | Suspensions |
| D020910 | Ketorolac |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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