Early Feasibility Study to Evaluate the Safety and Efficacy of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery
The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery. The study is conducted in two stages. The first stage (Stage 1/Phase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2/Phase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.
• Capable of giving signed informed consent.
• In good general and mental health without ongoing clinically significant abnormalities in medical history.
• Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.
• Successful, uncomplicated cataract surgery