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To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-TIC Low Dose | Experimental | Travoprost Intracameral Implant low dose |
|
| OTX-TIC High Dose | Experimental | Travoprost Intracameral Implant high dose |
|
| Durysta | Active Comparator | Bimatoprost Intracameral Implant 10 µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-TIC low dose Travoprost Intracameral Implant | Drug | OTX-TIC implant is injected into the anterior chamber of the eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Outcome: IOP changes from Baseline | IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye | Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 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. | Dothan | Alabama | 36301 | United States | ||
| Ocular Therapeutix, Inc. |
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Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
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Sponsor, Study Coordinator, Investigator
| OTX-TIC high dose Travoprost Intracameral Implant | Drug | OTX-TIC implant is injected into the anterior chamber of the eye. |
|
| Durysta, Bimatoprost Intracameral Implant 10 µg | Drug | Durysta is injected into the anterior chamber of the eye. |
|
| Huntington Beach |
| California |
| 92647 |
| United States |
| Ocular Therapeutix, Inc. | Irvine | California | 92604 | United States |
| Ocular Therapeutix, Inc. | Los Angeles | California | 90013 | United States |
| Ocular Therapeutix, Inc. | Pasadena | California | 91107 | United States |
| Ocular Therapeutix, Inc. | Petaluma | California | 94954 | United States |
| Ocular Therapeutix, Inc. | Redlands | California | 92373 | United States |
| Ocular Therapeutix, Inc. | Torrance | California | 90505 | United States |
| Ocular Therapeutix, Inc. | Clearwater | Florida | 33761 | United States |
| Ocular Therapeutiux, Inc. | Delray Beach | Florida | 33484 | United States |
| Ocular Therapeutix, Inc. | Fort Myers | Florida | 33901 | United States |
| Ocular Therapeutix, Inc. | Roswell | Georgia | 30076 | United States |
| Ocular Therapeutix, Inc. | Rock Island | Illinois | 61201 | United States |
| Ocular Therapeutix Inc | Carmel | Indiana | 46032 | United States |
| Ocular Therapeutix, Inc. | Saint Joseph | Michigan | 49085 | United States |
| Ocular Therapeutix, Inc. | Saint Joseph | Missouri | 49085 | United States |
| Ocular Therapeutix Inc. | St Louis | Missouri | 63110 | United States |
| Ocular Therapeutix, Inc. | Dover | New Jersey | 07801 | United States |
| Ocular Therapeutix, Inc. | Troy | New York | 12108 | United States |
| Ocular Therapeutix, Inc. | Durham | North Carolina | 27710 | United States |
| Ocular Therapeutiux, Inc. | Fargo | North Dakota | 58103 | United States |
| Ocular Therapeutix, Inc. | Cleveland | Ohio | 44106 | United States |
| Ocular Therapeutix Inc | Oklahoma City | Oklahoma | 73112 | United States |
| Ocular Therapeutix, Inc. | Cranberry Township | Pennsylvania | 16066 | United States |
| Ocular Therapeutix, Inc. | Philadelphia | Pennsylvania | 19107 | United States |
| Ocular Therapeutix, Inc. | Austin | Texas | 78701 | United States |
| Ocular Therapeutix, Inc. | Dallas | Texas | 75231 | United States |
| Ocular Therapeutix, Inc. | El Paso | Texas | 79902 | United States |
| Ocular Therapeutix, Inc. | Houston | Texas | 77030 | United States |
| Ocular Therapeutix, Inc. | Kenosha | Wisconsin | 53142 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 24, 2026 | Feb 10, 2026 | 4 | ||
| Mar 26, 2026 | Apr 14, 2026 | 5 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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