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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis
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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 |
|---|---|---|
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | 3 minutes |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | 5 minutes |
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | 7 minutes |
| Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | 7 minutes |
| Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | 15 minutes |
| Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | 20 minutes |
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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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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-DP | OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use |
| BG001 | Placebo Vehicle | PV (placebo drug delivery vehicle) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | Posted | Mean | Standard Deviation | units on a scale | 3 minutes |
|
|
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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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Events | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie L. Metzinger, Medical Affairs | Ocular Therapeutix | 781-357-4000 | jmetzinger@ocutx.com |
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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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Iris Color | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | Posted | Mean | Standard Deviation | units on a scale | 5 minutes |
|
|
|
| Primary | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | Posted | Mean | Standard Deviation | units on a scale | 7 minutes |
|
|
|
| Primary | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | Posted | Mean | Standard Deviation | units on a scale | 7 minutes |
|
|
|
| Primary | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | Posted | Mean | Standard Deviation | units on a scale | 15 minutes |
|
|
|
| Primary | Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None | Posted | Mean | Standard Deviation | units on a scale | 20 minutes |
|
|
|
| 35 |
| 0 |
| 35 |
| 3 |
| 35 |
| EG001 | Placebo Vehicle | PV (placebo drug delivery vehicle) | 0 | 38 | 0 | 38 | 4 | 38 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |