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To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza | Experimental | 1 dosing group - 37 eyes treated with Dextenza |
|
| Prednisolone | Active Comparator | 1 dosing group - 32 eyes treated with Prednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza Ophthalmic Insert | Drug | 0.4mg insert for intracanalicular use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs) | Up to approximately 42 days after surgery |
| Subject FLACC Pain Assessment | Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain). | From screening through day 42 |
| IOP | IOP measured in units of mmHg. | From screening, then day 2 through 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Therapeutix | Aurora | Colorado | 80045 | United States | ||
| Ocular Therapeutix |
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| Prednisolone acetate ophthalmic suspension USP 1% | Drug | 1 drop at end of surgery, followed by: 1 drop 4 x QID for one week. 1 drop 3 x QID for one week. 1 drop BID for one week. 1 drop QD for one week |
|
| Fort Collins |
| Colorado |
| 80525 |
| United States |
| Ocular Therapeutix | Jacksonville | Florida | 32202 | United States |
| Ocular Therapeutix | Indianapolis | Indiana | 46202 | United States |
| Ocular Therapeutix | Lexington | Kentucky | 40508 | United States |
| Ocular Therapeutix | Boston | Massachusetts | 02115 | United States |
| Ocular Therapeutix | Minneapolis | Minnesota | 55454 | United States |
| Ocular Therapeutix | Rochester | Minnesota | 55905 | United States |
| Ocular Therapeutix | St Louis | Missouri | 63110 | United States |
| Ocular Therapeutix | Erie | Pennsylvania | 16501 | United States |
| Ocular Therapeutix | Charleston | South Carolina | 29425 | United States |
| Ocular Therapeutix | Nashville | Tennessee | 37232 | United States |
| Ocular Therapeutix | Virginia Beach | Virginia | 23452 | United States |
| Ocular Therapeutix | Madison | Wisconsin | 53705 | United States |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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