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)
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- STATUS
- Recruiting
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- End date
- Jul 29, 2023
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- participants needed
- 105
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- sponsor
- Ocular Therapeutix, Inc.
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)
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.
Details
| Condition | Open Angle Glaucoma, Ocular Hypertension |
|---|---|
| Treatment | OTX-TIC low dose Travoprost Intracameral Implant, OTX-TIC high dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 µg |
| Clinical Study Identifier | NCT05335122 |
| Sponsor | Ocular Therapeutix, Inc. |
| Last Modified on | 29 April 2022 |
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