drugset / Trial / NCT03868124
Clinical Study Comparing Two Models of a Travoprost Intraocular Implant
RandomizedParallel-groupDouble-blindTreatment
Summary
Phase III study to compare the safety and efficacy of intraocular implants containing Travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (Timolol) in reducing elevated intraocular pressure in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT)
Timeline
- Start
- 2018-09-17
- Primary completion
- 2022-06-10
- Completion
- 2024-06-19
Publications
- Singh IP, Reiss GR, Flowers BE, Katz LJ, Usner DW, Applegate D, Kothe AC, Navratil T. Administration of the Travoprost Intracameral Implant in an Office-Based Surgery Setting. Ophthalmol Ther. 2025 Dec;14(12):3109-3118. doi: 10.1007/s40123-025-01254-4. Epub 2025 Oct 4.
- Singh IP, Berdahl JP, Sarkisian SR Jr, Voskanyan LA, Ang RE, Doan LV, Applegate D, Shen Y, Katz LJ, Kothe AC, Navratil T. Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials. Drugs. 2024 Oct;84(10):1299-1311. doi: 10.1007/s40265-024-02074-9. Epub 2024 Sep 6.
- Bacharach J, Doan LV, Stephens KG, Usner DW, Kothe AC, Katz LJ, Navratil T. Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2024 Sep;13(9):2357-2367. doi: 10.1007/s40123-024-00992-1. Epub 2024 Jul 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Timolol | Other / unclassified | 0.5 % | Topical |
| Subject | Travoprost | Other / unclassified | 75 ug | Other |