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The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension
This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-TP (sustained release travoprost) Intracanalicular Depot | Experimental | OTX-TP (sustained release travoprost) Intracanalicular Depot |
|
| PV (Placebo Vehicle) Intracanalicular Depot | Placebo Comparator | PV (Placebo Vehicle) Intracanalicular Depot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost | Drug |
| ||
| Placebo Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit | |
| Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit | |
| Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | Number of Participants with Serious Adverse Events | Through study completion, an average of 23 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | OTX-TP | Three forty eight (348) subjects were randomized to OTX-TP |
| FG001 | Placebo Vehicle (PV) | Two hundred seventeen (217) subjects were randomized to the PV. |
| 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 | May 2, 2017 | Apr 29, 2021 |
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| Other |
|
| Colorado Springs |
| Colorado |
| United States |
| Lakeland | Florida | United States |
| Morrow | Georgia | United States |
| Shawnee Mission | Kansas | United States |
| Des Peres | Missouri | United States |
| Rochester | New York | United States |
| Raleigh | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Austin | Texas | United States |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Three hundred forty eight (348) subjects were randomized to OTX-TP |
| BG001 | Placebo Vehicle (PV) | Two hundred seventeen (217) subjects were randomized to the PV. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Mean IOP | Posted | Mean | Standard Error | mmHg | Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit |
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| Primary | Mean IOP | Posted | Mean | Standard Error | mmHg | Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit |
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| Primary | Mean IOP | Posted | Mean | Standard Error | mmHg | Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit |
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| Other Pre-specified | Number of Participants With Serious Adverse Events | Number of Participants with Serious Adverse Events | Posted | Count of Participants | Participants | Through study completion, an average of 23 months |
|
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through study duration, an average of 23 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-TP (Sustained Release Travoprost) Intracanalicular Depot | Three hundred forty eight (348) subjects were randomized to OTX-TP | 1 | 348 | 7 | 348 | 132 | 348 |
| EG001 | Placebo Vehicle (PV) | Two hundred seventeen (217) subjects were randomized to the PV. | 0 | 217 | 6 | 217 | 65 | 217 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Event | Nervous system disorders | Systematic Assessment |
| ||
| Serious Adverse Event | Infections and infestations | Systematic Assessment |
| ||
| Serious Adverse Event | Cardiac disorders | Systematic Assessment |
| ||
| Serious Adverse Event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Serious Adverse Event | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Serious Adverse Event | Vascular disorders | Systematic Assessment |
| ||
| Serious Adverse Event | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Serious Adverse Events | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Serious Adverse Event | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Ocular Therapeutix, Inc. | 781-357-4000 | clinicalaffairs@ocutx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2018 | Apr 29, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| >=65 years |
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| Male |
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| African American |
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| Other |
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| 4PM |
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