Steven R Sarkisian, Robert E Ang, Andy M Lee, John P Berdahl, Sebastian B Heersink, James H Burden, Long V Doan, Kerry G Stephens, Angela C Kothe, Dale W Usner, L Jay Katz, Tomas Navratil
PURPOSE: Evaluate the safety and intraocular pressure (IOP)-lowering efficacy of two models of the travoprost intraocular implant (fast-eluting [FE-implant] and slow eluting [SE-implant]) from one of two pivotal trials (GC-010). DESIGN: Phase 3, multicenter, randomized, double-masked, sham-controlled, non-inferiority trial. PARTICIPANTS: Subjects with open-angle glaucoma or ocular hypertension, using 0 to 3 IOP-lowering medications at screening and having an unmedicated baseline mean diurnal IOP (average of 8AM, 10AM and 4PM timepoints) of ≥ 21 mmHg, and an unmedicated baseline IOP of ≤ 36 mmHg at each timepoint in the study eye...
February 27, 2024: Ophthalmology