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The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-DP | Experimental | OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use |
|
| PV | Placebo Comparator | PV (placebo drug delivery vehicle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
| ||
| Placebo Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Anterior Chamber Inflammation | Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14 | Day 14 |
| Absence of Ocular Pain | Absence of pain (i.e., score of '0') in the study eye at Day 8 | Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-DP | OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use |
| FG001 | Placebo Vehicle | PV (placebo drug delivery vehicle) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| COMPLETED |
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| NOT COMPLETED |
|
All randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-DP | OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use |
| BG001 | Placebo Vehicle | PV (placebo drug delivery vehicle) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Iris Color | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absence of Anterior Chamber Inflammation | Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14 | ITT LOCF (last observation carried forward) | Posted | Number | percentage of total participants | Day 14 |
|
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| |||||||||||||||||||||||||||||
| Primary | Absence of Ocular Pain | Absence of pain (i.e., score of '0') in the study eye at Day 8 | ITT LOCF (last observation carried forward) | Posted | Number | percentage of total participants | Day 8 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OTX-DP | OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | 0 | 216 | 3 | 216 | 63 | 216 |
| EG001 | Placebo Vehicle | PV (placebo drug delivery vehicle) | 0 | 221 | 2 | 221 | 86 | 221 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders |
| |||
| Cardiac failure acute | Cardiac disorders |
| |||
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Events | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie L. Metzinger, Medical Affairs | Ocular Therapeutix | 781-357-4000 | jmetzinger@ocutx.com |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Blue |
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| Hazel |
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| Green |
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| Gray |
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| Black |
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