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To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-TIC-Cohort 1 | Experimental | 15 µg (formulation1) implant |
|
| OTX-TIC-Cohort 2 | Experimental | 26 µg (formulation1) implant |
|
| OTX-TIC-Cohort 3 | Experimental | 15 µg (formulation 2) implant |
|
| OTX-TIC-Cohort 4 | Experimental | 5 µg (formulation 3) implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-TIC | Drug | OTX-TIC implant is injection in the anterior chamber of the eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Treatment Emergent Adverse Events | All adverse events will be captured throughout the study | Through study completion, 6 months |
| Efficacy Outcome | IOP measurements at 8 am | Diurnal IOP [12 Week Visit] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Therapeutix, Inc. | Petaluma | California | 94954 | United States | ||
| Ocular Therapeutix, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-TIC-Cohort 1 | 15 µg (formulation1) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| FG001 | OTX-TIC-Cohort 2 | 26 µg (formulation1) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| FG002 | OTX-TIC-Cohort 3 | 15 µg (formulation 2) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| FG003 | OTX-TIC-Cohort 4 | 5 µg (formulation 3) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-TIC-Cohort 1 | 15 µg (formulation1) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| BG001 | OTX-TIC-Cohort 2 | 26 µg (formulation1) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| 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 Treatment Emergent Adverse Events | All adverse events will be captured throughout the study | Posted | Number | Number of Treatment-Emergent Events | Through study completion, 6 months |
|
6 months
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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-TIC-Cohort 1 | 15 µg (formulation1) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital, familial and genetic disorders | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Ocular Therapeutix | 7813574000 | clinicalaffairs@ocutx.com |
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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 | Jul 28, 2020 | Feb 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2020 | Feb 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
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| Torrance |
| California |
| 90505 |
| United States |
| Ocular Therapeutix, Inc | Roswell | Georgia | 30076 | United States |
| Ocular Therapeutix, Inc. | Austin | Texas | 78731 | United States |
| Ocular Therapeutix, Inc. | Racine | Wisconsin | 53405 | United States |
| BG002 | OTX-TIC-Cohort 3 | 15 µg (formulation 2) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| BG003 | OTX-TIC-Cohort 4 | 5 µg (formulation 3) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
15 µg (formulation 2) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
| OG003 | OTX-TIC-Cohort 4 | 5 µg (formulation 3) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye |
|
|
| Primary | Efficacy Outcome | IOP measurements at 8 am | Posted | Mean | Standard Deviation | mmHg mean IOP change at wk12 from bln | Diurnal IOP [12 Week Visit] |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | OTX-TIC-Cohort 2 | 26 µg (formulation1) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | OTX-TIC-Cohort 3 | 15 µg (formulation 2) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye | 0 | 5 | 0 | 5 | 3 | 5 |
| EG003 | OTX-TIC-Cohort 4 | 5 µg (formulation 3) implant OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye | 0 | 5 | 0 | 5 | 1 | 5 |
| Eye Disorders | Eye disorders | Non-systematic Assessment |
|
| Uncoded Terms | Eye disorders | Non-systematic Assessment | Uncoded terms in Cohort 3 consisted of 2 events of corneal edema in the Study Eye and an event of fixed and dilated pupil in the Study Eye |
|
| Investigations | Eye disorders | Non-systematic Assessment |
|
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