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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 | Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching) | 14 days post insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Redness | Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness) | 14 days post insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-DP Treatment | OTX-DP (sustained release dexamethasone, 0.4 mg) OTX-DP treatment |
| FG001 | Placebo Plug Delivery Vehicle | Placebo Plug with no drug Placebo Plug with no drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-DP Treatment | OTX-DP (sustained release dexamethasone, 0.4 mg) OTX-DP treatment |
| BG001 | Placebo Plug Delivery Vehicle | Placebo Plug with no drug Placebo Plug with no drug |
| 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 | Ocular Itching | Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching) | Posted | Mean | Standard Deviation | units on a scale (0 -4) | 14 days post insertion |
|
|
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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 Treatment | OTX-DP (sustained release dexamethasone, 0.4 mg) OTX-DP treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| depression | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye discharge | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Ocular Therapeutix, Inc. | 781-357-4000 | dmulani@ocutx.com |
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Conjunctival Redness | Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness) | Posted | Mean | Standard Deviation | units on a scale (0 - 4) | 14 days post insertion |
|
|
|
| 1 |
| 31 |
| 1 |
| 31 |
| EG001 | Placebo Plug Delivery Vehicle | Placebo Plug with no drug Placebo Plug with no drug | 0 | 33 | 2 | 33 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 20 min. (14 days post-insertion) |
|