A Phase 3 Study of Bimatoprost Implant with SpyGlass IOL Versus Timolol Eye Drops for Treating Mild to Moderate Open-Angle Glaucoma or Ocular Hypertension in Patients Undergoing Cataract Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Bimatoprost Implant System combined with the SpyGlass Intraocular Lens IOL compared to Timolol Maleate Ophthalmic Solution 0.5% in adults with mild to moderate open-angle glaucoma or ocular hypertension who are undergoing cataract surgery. This study is a phase 3, randomized, double-masked controlled trial sponsored by SpyGlass Pharma, Inc. It aims to explore new options to manage eye pressure during cataract treatment. Participants will receive either the Bimatoprost Implant System with the SpyGlass IOL or Timolol Maleate Ophthalmic Solution 0.5%, administered twice daily. The Bimatoprost Implant System is used in combination with the SpyGlass IOL, while the comparator group receives Timolol eye drops. The study involves a controlled comparison between these treatments to assess their impact on eye pressure and visual acuity. Throughout the study, participants will be monitored for changes in intraocular pressure IOP at weeks 2, 6, and month 3, with additional assessments at months 6, 9, and 12. Visual acuity is also evaluated at month 6. Safety and efficacy data will be collected during these visits to measure treatment outcomes and monitor any adverse effects. The total study duration extends until March 2031, allowing for long-term follow-up and observation.

Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)