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To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.
Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-DED 0.2mg | Experimental | Approximately 50 subjects |
|
| OTX-DED 0.3mg | Experimental | Approximately 50 subjects |
|
| Hydrogel Vehicle (HV) | Placebo Comparator | Approximately 50 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-DED | Drug | 0.2mg dexamethasone ophthalmic insert |
| |
| OTX-DED |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). | The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia [evaluated by the central reading center (CRC)] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia. | Change from baseline (Day 1) at Visit 4 (Day 15) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Therapeutix | Inglewood | California | 90301 | United States | ||
| Ocular Therapeutix, Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert | Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert |
| FG001 | OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2020 | Nov 4, 2022 |
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Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
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| Drug |
0.3mg dexamethasone ophthalmic insert |
|
| OTX-DED | Drug | Hydrogel vehicle ophthalmic insert |
|
| Mission Hills |
| California |
| 91345 |
| United States |
| Ocular Therapeutix, Inc. | Newport Beach | California | 92663 | United States |
| Ocular Therapeutix, Inc. | Santa Ana | California | 92705 | United States |
| Ocular Therapeutix, Inc. | Delray Beach | Florida | 33484 | United States |
| Ocular Therapeutix, Inc. | Largo | Florida | 33773 | United States |
| Ocular Therapeutix | Warrenville | Illinois | 60555 | United States |
| Ocular Therapeutix, Inc. | Indianapolis | Indiana | 46260 | United States |
| Ocular Therapeutix | Kansas City | Missouri | 64111 | United States |
| Ocular Therapeutix, Inc. | St Louis | Missouri | 63131 | United States |
| Ocular Therapeutix | Poughkeepsie | New York | 12603 | United States |
| Ocular Therapeutix, Inc. | Raleigh | North Carolina | 27603 | United States |
| Ocular Therapeutix, Inc. | Cranberry Township | Pennsylvania | 16066 | United States |
| Ocular Therapeutix, Inc. | Memphis | Tennessee | 38119 | United States |
| Ocular Therapeutix, Inc. | League City | Texas | 77573 | United States |
Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert
| FG002 | Hydrogel Vehicle (HV) Intracanalicular Insert | Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert |
| COMPLETED |
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| NOT COMPLETED |
|
The Modified Intent-to-Treat (mITT) analysis set includes all subjects in the Intent-to-Treat (ITT) population who received IP (OTX-DED or HV) in the study eye.
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert | Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert |
| BG001 | OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert | Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert |
| BG002 | Hydrogel Vehicle (HV) Intracanalicular Insert | Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert |
| BG003 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). | The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia [evaluated by the central reading center (CRC)] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia. | mITT population: CFB in Photographic Assessment of Bulbar Conjunctival Hyperemia in the Worst Zone (highest grading score at baseline among nasal, temporal, and frontal zones) of Study Eye at Day 15 | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from baseline (Day 1) at Visit 4 (Day 15) |
|
|
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Through study completion, an average of 10 weeks.
This analysis includes the Modified Intent To Treat (mITT) analysis set which includes all subjects in the Intent To Treat (ITT) population who received IP (OTX-DED or HV) in the study 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 | OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert | Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert | 0 | 55 | 0 | 55 | 5 | 55 |
| EG001 | OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert | Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert | 0 | 56 | 0 | 56 | 10 | 56 |
| EG002 | Hydrogel Vehicle (HV) Intracanalicular Insert | Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert | 0 | 55 | 2 | 55 | 6 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis/Worsening of Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Ocular Therapeutix | 781-357-4000 | clinicalaffairs@ocutx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2021 | Nov 4, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Male |
|
| Asian |
|
| 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 |
|
| Unknown or Not Reported |
|