A5093440376- Glaucoma and retinal disorders
- Corneal surgery and disorders
- Ocular Surface and Contact Lens
- Retinal Diseases and Treatments
- Intraocular Surgery and Lenses
Glaukos (United States)
2023-2025
This prospective, multicenter, randomized, double-masked pivotal phase 3 trial evaluated the efficacy and safety of travoprost intracameral SE-implant (slow-eluting implant, intended commercial product) FE-implant (fast-eluting included primarily for masking purposes) compared to twice-daily (BID) timolol ophthalmic solution, 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The enrolled adult OAG OHT an unmedicated mean diurnal intraocular pressure (IOP) ≥ 21 IOP...
A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed provide uninterrupted sustained pressure (IOP)-lowering therapy, thereby reducing patient treatment burden improving adherence with IOP-lowering medication. Patients open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE n = 51) received twice-daily (BID) placebo eye drops,...
Background: The travoprost intracameral implant and cataract surgery both lower intraocular pressure (IOP). Objectives: We evaluated the safety IOP-lowering effect at 3 months following administration of in combination with surgery. Design: Prospective, 12-month, open-label, single-arm trial. Methods: enrolled patients age-related cataracts open-angle glaucoma or ocular hypertension same eye. At baseline, were required to have an unmedicated mean diurnal IOP (average 8:00 am, 10:00 4:00 pm...
This was a prospective, randomized, double-masked, multicenter, 24-month study to compare effectiveness and safety outcomes following standalone implantation of two types current generation trabecular stents in adults with open-angle glaucoma (OAG). An interim analysis performed at month 6. Eyes OAG, mean IOP ≤ 24 mmHg on zero three intraocular pressure (IOP)-lowering medications screening, baseline diurnal (MDIOP) 21-36 after medication washout were randomized the micro-bypass (iStent...
To determine the aqueous humor (AH) exposure to travoprost free acid (TFA) and in vivo elution rate of over a 24-month period subjects with open-angle glaucoma administered intracameral implant, 75 µg. In this prospective, single-center, open-label study, 210 (7 cohorts 30 each) were implant followed for 3-24 months. At pre-determined timepoints (3, 6, 12, 15, 18, 21, 24 months), AH was collected, new administered, prior removed. samples assayed TFA concentrations using validated liquid...
This study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of slow-eluting (SE) travoprost intracameral implant IOP topical prostaglandin analog (PGA) monotherapy in a subgroup subjects who were on pre-study PGA prior enrollment two pivotal phase 3 trials implant. A combined population 133 from trials, at screening, subsequently underwent washout period their PGA, then randomized administered an SE The analyzed for effects in-study Paired t-tests used...