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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.
Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracanalicular Sustained Release Dexamethasone, 0.4 mg | Experimental | Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery. |
|
| topical prednisolone acetate 1%. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza | Drug | Intracanalicular sustained release dexamethasone insert 0.4 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in pain score | Average change in pain based on whats reported on the Ocular Pain Assessment | 30 Days |
| Post-op pain scores | Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in anterior chamber cell and flare score | Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Finnen, MD | Midwest Medical Advisors, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
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| Prednisolone Acetate | Drug | Topical Prednisolone acetate 1% ophthalmic suspension |
|
| Cystoid Macular Edema | Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT) | 30 days |
| Best Corrected Visual Acuity | As measured on ETDRS | 90 days |
| Physician Ease of Dextenza insertion | The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome. | Day 1 |
| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| C009935 | prednisolone acetate |
| 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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