000168368 001__ 168368 000168368 005__ 20260204153543.0 000168368 0247_ $$2doi$$a10.2147/OPTH.S454721 000168368 0248_ $$2sideral$$a147822 000168368 037__ $$aART-2025-147822 000168368 041__ $$aeng 000168368 100__ $$aStalmans, Ingeborg 000168368 245__ $$aFifteen-Month Outcomes of Preservative-Free Latanoprost Cationic Emulsion in Open-Angle Glaucoma and Ocular Hypertension: Phase III Open-Label Extension of a Randomized Trial 000168368 260__ $$c2025 000168368 5060_ $$aAccess copy available to the general public$$fUnrestricted 000168368 5203_ $$aPurpose: 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. 000168368 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttps://creativecommons.org/licenses/by-nc/4.0/deed.es 000168368 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000168368 700__ $$aBaudouin, Christophe 000168368 700__ $$0(orcid)0000-0002-6745-7668$$aLarrosa, Jose Manuel$$uUniversidad de Zaragoza 000168368 700__ $$aSchmickler, Stefanie 000168368 700__ $$aOddone, Francesco 000168368 7102_ $$11013$$2646$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Oftalmología 000168368 773__ $$g19 (2025), 4635-4650$$pClin. Ophthalmol.$$tClinical Ophthalmology$$x1177-5467 000168368 8564_ $$s5742413$$uhttps://zaguan.unizar.es/record/168368/files/texto_completo.pdf$$yVersión publicada 000168368 8564_ $$s2598196$$uhttps://zaguan.unizar.es/record/168368/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000168368 909CO $$ooai:zaguan.unizar.es:168368$$particulos$$pdriver 000168368 951__ $$a2026-02-04-13:14:39 000168368 980__ $$aARTICLE