drugset / Trial / NCT03519386
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
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
- 2018-07-26
- Primary completion
- 2022-04-05
- Completion
- 2024-04-02
Outcome
Met primary endpoint
paper The SE-implant was non-inferior to timolol eye drops in IOP lowering over the first 3 months PMID 38345710 ↗
paper The FE-implant was non-inferior to timolol over the first 3 months PMID 38345710 ↗
Publications
- 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.
- Sarkisian SR, Ang RE, Lee AM, Berdahl JP, Heersink SB, Burden JH, Doan LV, Stephens KG, Applegate D, Kothe AC, Usner DW, Katz LJ, Navratil T. Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial. Ophthalmol Ther. 2024 Apr;13(4):995-1014. doi: 10.1007/s40123-024-00898-y. Epub 2024 Feb 12.
- Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Timolol | Other / unclassified | 0.5 % | Topical |
| Subject | Travoprost | Other / unclassified | 75 ug | Other |