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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 compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXTENZA | Experimental | DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use |
|
| Antihistamine | Active Comparator | PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration. |
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| Topical Steroid | Active Comparator | ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone ophthalmic insert 0.4Mg | Drug | Dextenza 0.4Mg Ophthalmic Insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit) | Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit) | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
• Known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 0.2% loteprednol etabonate ophthalmic suspension | Drug | 0.2% loteprednol etabonate ophthalmic suspension |
|
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| olopatadine hydrochloride ophthalmic solution 0.7% | Drug | olopatadine hydrochloride ophthalmic solution 0.7% |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |