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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004686-18 | EudraCT Number |
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This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Experimental | Indomethacin ophthalmic solution 0.1% for post-surgical inflammation |
|
| Ketorolac | Active Comparator | Ketorolac ophthalmic solution 0.5% for post-surgical inflammation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin ophthalmic solution | Drug | Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous flare | Post-operative day 1 & day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous flare | Postoperative day 30 and day 90 | |
| Change from baseline of retinal thickness | Postoperative day 30 & day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriele Brenger | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Berlin | D 13581 | Germany |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Ketorolac Ophthalmic Solution | Drug | Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery |
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