Fifteen-Month Outcomes of Preservative-Free Latanoprost Cationic Emulsion in Open-Angle Glaucoma and Ocular Hypertension: Phase III Open-Label Extension of a Randomized Trial

Stalmans, Ingeborg ; Baudouin, Christophe ; Larrosa, Jose Manuel (Universidad de Zaragoza) ; Schmickler, Stefanie ; Oddone, Francesco

Resumen: Purpose: Reporting of open-label extension data following a Phase III, randomized study examining treatment outcomes with preservative-free latanoprost eye drop cationic emulsion and preserved latanoprost in patients with open-angle glaucoma (OAG)/ocular hypertension (OHT).
Patients and Methods: OAG/OHT patients were randomized 1:1 to receive preservative-free latanoprost 0.005% eye drop emulsion or preserved latanoprost 0.005% for 12 weeks. Patients entering the extension study received open-label preservative-free latanoprost eye drop emulsion from Week 12 through Month 15. Endpoints included mean (standard deviation [SD]) change from baseline (Day 1, post-washout) in peak (9:00 AM ± 1 hour) intraocular pressure (IOP), corneal fluorescein staining (CFS; modified Oxford Grade Scale) score, ocular surface disease (OSD) symptom score and adverse event (AE) reporting.
Results: Respective mean (SD) peak (9:00 AM) IOP reductions from baseline at Week 12, and Months 6, 9 and 15 were 8.9 (3.0), 8.9 (3.0), 9.0 (2.7) and 8.7 (2.3) mmHg for preservative-free latanoprost eye drop emulsion users (N=70) and 7.8 (2.6), 8.3 (2.6), 8.1 (2.7) and 7.6 (2.8) mmHg for patients switching from preserved latanoprost at Week 12 (N=66). Between-group differences for the change in IOP were statistically significant at Week 12 (– 1.06; nominal p=0.029). Mean CFS and OSD symptoms scores were reduced in both groups through Month 15. No serious treatment-related AEs were reported during the study period.
Conclusion: Open-label preservative-free latanoprost eye drop emulsion treatment provided dual benefit of sustained IOP-lowering efficacy and improvements in OSD signs and symptoms over the 15-month study period. No serious treatment-related AEs were reported throughout the study period.

Idioma: Inglés

DOI: 10.2147/OPTH.S454721

Año: 2025

Publicado en: Clinical Ophthalmology 19 (2025), 4635-4650
ISSN: 1177-5467

Tipo y forma: Article (Published version)

Área (Departamento): Área Oftalmología (Dpto. Cirugía)