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To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-DP (Dexamethasone Punctum Plug) | Active Comparator | Resorbable hydrogel drug delivery vehicle containing dexamethasone |
|
| PVPP (Placebo Punctum Plug) | Placebo Comparator | Resorbable hydrogel drug delivery vehicle containing no drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
| ||
| Punctum Plug |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Cells in Anterior Chamber of the Study Eye | Day 14 | |
| Absence of Pain in Study Eye | Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Manager | Ocular Therapeutix | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texan Eye / Keystone Research, Ltd. | Austin | Texas | 78731 | United States |
One subject inadvertently received PVPP instead of OTX-DP, as they had been randomized. This subject was followed safety but not included in the PP analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-DP (Dexamethasone Punctum Plug) | Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug |
| FG001 | PVPP (Placebo Punctum Plug) | Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-DP (Dexamethasone Punctum Plug) | Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug |
| BG001 | PVPP (Placebo Punctum Plug) | Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Cells in Anterior Chamber of the Study Eye | Posted | Count of Participants | Participants | Day 14 |
|
|
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One subject was inadvertently treated with PVPP instead of OTX-TP, as they had been randomized. This subject was not included in the PP, but was followed for safety.
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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 (Dexamethasone Punctum Plug) | Resorbable hydrogel drug delivery vehicle containing dexamethasone Dexamethasone Punctum Plug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypopyon | Eye disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| inflammation | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Ocular Therapeutix, Inc. | 781-357-4000 | dmulani@ocutx.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Absence of Pain in Study Eye | Posted | Count of Participants | Participants | Day 8 |
|
|
|
| 0 |
| 162 |
| 37 |
| 162 |
| EG001 | PVPP (Placebo Punctum Plug) | Resorbable hydrogel drug delivery vehicle containing no drug Punctum Plug | 1 | 84 | 31 | 84 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |