Trials / Completed
CompletedNCT05335122
A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Ocular Therapeutix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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)
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTX-TIC low dose Travoprost Intracameral Implant | OTX-TIC implant is injected into the anterior chamber of the eye. |
| DRUG | OTX-TIC high dose Travoprost Intracameral Implant | OTX-TIC implant is injected into the anterior chamber of the eye. |
| DRUG | Durysta, Bimatoprost Intracameral Implant 10 µg | Durysta is injected into the anterior chamber of the eye. |
Timeline
- Start date
- 2022-03-16
- Primary completion
- 2024-01-24
- Completion
- 2025-01-24
- First posted
- 2022-04-19
- Last updated
- 2025-03-21
Locations
30 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05335122. Inclusion in this directory is not an endorsement.