An Open-label, Observational, Non-comparative, Real world Study with Fixed dose combination (FDC) of Timolol 0.5%, Brimonidine 0.2% and Brinzolamide 1% eye drops (Trisopt) in patients with glaucoma or ocular hypertension

This clinical study is an open-label, observational, non-comparative, real-world investigation designed to evaluate the efficacy and safety of a fixed dose combination (FDC) of Timolol 0.5%, Brimonidine 0.2%, and Brinzolamide 1% eye drops (Trisopt) in patients with glaucoma or ocular hypertension. Conducted over a 12-week period, the study aims to assess the reduction in intraocular pressure (IOP) as the primary endpoint, with secondary outcomes focused on safety and tolerability, including monitoring adverse events and changes in ophthalmological parameters. A total of 120 subjects are planned for enrollment to account for a potential 20% dropout, ensuring that at least 100 patients complete the study. Participants receive one drop of the FDC twice daily in the affected eye(s), and are followed up at baseline, optionally at Week 2, and mandatorily at Weeks 8 and 12. The study is investigator-initiated and complies with ethical guidelines including ICH-GCP, Schedule Y, and the Declaration of Helsinki, with approval from an independent ethics committee and proper informed consent procedures. Data will be analyzed using SPSS software with descriptive statistics to determine clinical outcomes.