Evaluating the Safety and Effectiveness of TFC-003 Eye Drops in Adults with Primary Open-Angle Glaucoma or Ocular Hypertension

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a drug called TFC-003 in adults diagnosed with primary open-angle glaucoma or ocular hypertension. This phase 3 study aims to compare TFC-003 with other similar drug formulations to understand their impact on eye pressure, which is critical in managing these eye conditions. Participants will receive one of three treatments TFC-003 administered twice daily as eye drops, TFC-003-R1 also given twice daily, or a combination of two eye drops, TFC-003-R2 and TFC-003-R3, both given twice daily with at least a 10-minute gap between them. The treatments are given approximately at 830 AM and 830 PM each day. Each participant will be randomly assigned to one of these treatment groups in a parallel study design. During the study, participants will have their intraocular pressure measured at the start and at weekly intervals up to 24 weeks. The main outcome is the change in eye pressure over 12 weeks, with additional assessments extending to 24 weeks. Participants will be monitored closely through scheduled visits to ensure adherence to the treatment and to evaluate safety and effectiveness throughout the study period.

[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension