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Not currently pursuing indication
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A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXYCU | Experimental | DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg |
|
| Placebo | Placebo Comparator | Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexycu | Drug | 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8 | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30 | Days 1, 3, 15, and 30 | |
| Mean ocular pain scores in the study eye | Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
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Triple (Participant, Investigator, Outcomes Assessor)
| Placebo/Vehicle |
| Other |
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg |
|
| Days 1, 3, 15, and 30 |
| Proportion of subjects with absence of cells in the AC of the study eye | Days 1, 3, 15, and 30 |
| Proportion of subjects with absence of flare in the AC of the study eye | Days 1, 3, 15, and 30 |
| Mean AC cell score in the study eye | AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe | Days 1, 3, 15, and 30 |
| Mean AC flare score in the study eye | AC flare by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity | Days 1, 3, 15, and 30 |
| Rates of ocular (study eye and fellow eye) and non-ocular TEAEs | up to day 30 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |