Phase 2Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the second generation travoprost intracameral implant compared to timolol 0.5 eye drops in adults with open-angle glaucoma or ocular hypertension. This trial includes both Phase 2 and Phase 3 portions and aims to understand how well this implant works to control eye pressure over time. Participants will either receive the travoprost implant along with placebo eye drops twice daily or timolol 0.5 eye drops twice daily with a sham procedure in their study eye. The study includes a single-arm open-label Phase 2 portion followed by randomized, double-masked, active-controlled phases. In Phase 3, some participants will undergo implant exchange procedures at months 12, 24, and 36 and will be followed for an additional 12 months after each exchange. During the study, participants will be monitored for eye pressure changes, with intraocular pressure measured at 3 months as the primary outcome. They will be followed for up to 36 months in Phase 2 and up to 48 months in Phase 3 depending on the implant exchange schedule. Researchers will assess safety and treatment effects through regular visits, with adherence to eye drop use and procedures closely tracked.

Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant