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Inability to enroll due to lack of access to the Ambulatory Surgery Center.
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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)
The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza 0.4mg | Experimental | Intracanalicular insert |
|
| Durezol 0.05% | Active Comparator | difluprednate ophthalmic emulsion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4mg intracanalicular Insert | Drug | intracanalicular insert delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure from Baseline | Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline. | 30 days - IOP measured at day 1, day 14 and day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathleen M McCabe, MD | The Eye Associates of Manatee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Associates of Manatee | Bradenton | Florida | 34209 | United States |
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| Label | URL |
|---|---|
| Sponsor/ site website | View source |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| C015808 | difluprednate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Open label prospective randomized comparative investigator -initiated study
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| Durezol 0.05% Ophthalmic Emulsion | Drug | Standard therapy, topical steroid drop |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |