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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 ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Punctum Plug | Active Comparator | Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days |
|
| Placebo Vehicle Punctum Plug | Placebo Comparator | Placebo punctum plug insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-DP (Dexamethasone punctum plug) | Drug | Sustained and tapered release of dexamethasone from hydrogel punctum plug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Cells in Anterior Chamber of Study Eye | Day 8 | |
| Absence of Pain in the Study Eye | Day 8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Measure of adverse events over the duration of each subject's participation in the study. | Duration of each individual subject's participation in the study, up to 60 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois | 60169 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Punctum Plug | Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug |
| FG001 | Placebo Vehicle Punctum Plug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Vehicle Punctum Plug | Drug | Hydrogel punctum plug without dexamethasone |
|
Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone Punctum Plug | Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug |
| BG001 | Placebo Vehicle Punctum Plug | Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone |
| 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, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | 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 Cells in Anterior Chamber of Study Eye | Posted | Count of Participants | Participants | Day 8 |
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| Primary | Absence of Pain in the Study Eye | Posted | Count of Participants | Participants | Day 8 |
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| Other Pre-specified | Adverse Events | Measure of adverse events over the duration of each subject's participation in the study. | Ocular adverse events | Posted | Count of Participants | Participants | Duration of each individual subject's participation in the study, up to 60 days |
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The analyses of safety were based primarily on the incidence of treatment-emergent adverse events up to 60 days.
The number of subjects in the OTX-DP group is confirmed as 29, one subject was not treated due to the inability to insert the plug in either eye.
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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 | Dexamethasone Punctum Plug | Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug | 0 | 29 | 3 | 29 | ||
| EG001 | Placebo Vehicle Punctum Plug | Placebo punctum plug insertion Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone | 1 | 30 | 10 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders | Eye disorders | Visual Acuity Reduced, Conjunctival Hyperemia, Corneal Edema, Anterior Chamber Inflammation, Conjunctival Hemorrhage, Cystoid Macular Edema, Eye Discharge, Eye Disorder, Eye Pain, Iritis, Lenticular Opacities, Photophobia |
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The PIs agree that the first publication of the data and results of the Study shall be made in conjunction with the presentation of a joint, multi-center publication of the Study results, with the investigators from all appropriate sites contributing data, analyses, and comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Ankerud | Ocular Therapeutix, Inc. | 781-357-4013 | eankerud@ocutx.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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