Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg | Experimental | Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug) |
|
| Omidria + Dexycu | Experimental | Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension |
|
| Omidria + Prednisolone Acetate 1% | Active Comparator | Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omidria | Drug | phenylephrine 1% and ketorolac 0.3% intraocular solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of anterior chamber inflammation | The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute. | Assessed at day 8 post-operatively |
| Resolution of anterior chamber inflammation | The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute. | Assessed at day 15 post-operatively |
| Resolution of anterior chamber inflammation | The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute. | Assessed at day 30 post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of postoperative pain | The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment). | Assessed at day 1 post-operatively |
| Resolution of postoperative pain |
| Measure | Description | Time Frame |
|---|---|---|
| Optical Coherence Tomography (OCT) | OCT is a non-contact, non-invasive test that takes less than a minute to perform. All that is required of the patient is that they sit still and look at a fixation light while the machine takes a picture. No eye drops or any other intervention are required. OCT scanning will provide an image of the deep layers of the retina and will be used to determine macular thickness measurement (macular thickness has been correlated to changes in contrast sensitivity) before and 30 days following surgery. . |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
Not provided
Patients will be randomly assigned to 1 of 3 groups (1:1:1), each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria.
Not provided
Not provided
Not provided
Not provided
| Dextenza (dexamethasone ophthalmic insert) 0.4mg | Drug | intracanalicular dexamethasone insert |
|
| Dexycu, 9% Intraocular Suspension | Drug | dexamethasone intraocular suspension |
|
| Prednisolone Acetate 1% | Drug | standard postoperative ophthalmic drop regimen |
|
The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment). |
| Assessed at day 8 post-operatively |
| Assessed pre-operatively and 1 month post-operatively |
| Contrast sensitivity testing | This test is non-contact, non-invasive and used to distinguish between finer and finer increments of light versus dark. The patient simply looks at a chart similar to the Snellen Eye Chart and distinguishes lighter shades from darker shades. The test is performed in less than one minute. | Assessed pre-operatively, and at 15 days and 30 days post-operatively |
| Best corrected visual acuity | ETDRS chart at 4m | Assessed pre-operatively, and at 15 days and 30 days post-operatively |
| Optical Coherence Tomography (OCT) | OCT is a non-contact, non-invasive test that takes less than a minute to perform. All that is required of the patient is that they sit still and look at a fixation light while the machine takes a picture. No eye drops or any other intervention are required. OCT scanning will provide an image of the deep layers of the retina and will be used to evaluate for the presence of cystoid macular edema before and 30 days following surgery. | Assessed pre-operatively and 1 month post-operatively |
| 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 |
Not provided
Not provided