A phase III study comparing preservative-free latanoprost eye drop emulsion with preserved latanoprost in open-angle glaucoma or ocular hypertension

Baudouin, Christophe ; Stalmans, Ingeborg ; Bourne, Rupert ; Larrosa, Jose Manuel ; Schmickler, Stefanie ; Seleznev, Aleksey ; Oddone, Francesco ; El-Shabrawi, Yosuf ; Garhoefer, Gerhard ; Mossboeck, Georg ; Stalmans, Ingeborg ; Kaljurand, Kuldar ; Noor, Kai ; Jugaste, Tia ; Kaarniranta, Kai ; Baudouin, Christophe ; Santiago, Pierre Yves ; Labetoulle, Marc ; Schweitzer, Cedric ; Vabres, Bertand ; Lorenz, Katrin ; Schuart, Claudia ; Spitzer, Martin ; Hamacher, Thomas ; Schmickler, Stefanie ; Thelen, Ulrich ; Oddone, Franceso ; Barabino, Stefano ; Manni, Gianluca ; Leonardi, Andrea ; Rossi, Gemma Caterina Maria ; Lanzetta, Paolo ; Baumane, Kristine ; Lagnovska, Guna ; Grundmane, Iveta ; Rekas, Marek ; Siewierska, Malgorzata ; Mrukwa-Kominek, Ewa ; Fryczkowski, Piotr ; Malyugin, Boris ; Lebedev, Oleg Ivanovich ; Bratko, Galina ; Astakhov, Turiy Sergeevich ; Boiko, Ernest Vitalyevich ; Abduleva, Elmira ; Gavrilova, Natalia Aleksandrovna ; Gornostaeva, Ekaterina ; Seleznev, Aleksey ; Pozdeeva, Nadezhda ; Molokov, Kirill ; Kim, Chan Yun ; Park, Ki Ho ; Park, Chan Kee ; Belda, Jose I. ; Lopez, Fernando Lopez ; Larrosa, José Manuel (Universidad de Zaragoza) ; Feijóo, Julián García ; Pazos, Marta ; Morena-Montañes, Javier ; Calvo, Pedro Pablo Rodriguez ; Canut, Maria Isabel ; López, Alfonso Antón ; Hanspal, Inderraj ; Bourne, Rupert ; Kirwan, James ; Cordeiro, Francesca [...] Show all 66 authors

Resumen: Background/Objectives: To evaluate the efficacy and safety of preservative-free latanoprost eye drop emulsion in reducing intraocular pressure (IOP) versus preserved latanoprost in open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods: A Phase III non-inferiority study randomised patients with OAG/OHT 1:1 to receive preservative-free latanoprost eye drop emulsion or preserved latanoprost. The primary efficacy endpoint was change from baseline in peak (9:00 A.M. ± 1 h) and trough (4:00 P.M. ± 1 h) IOP at Week 12 (non-inferiority margin: 95% confidence interval for treatment difference of ≤1.5 mmHg). Key secondary endpoints were change from baseline in corneal fluorescein staining (CFS) score and in ocular surface disease (OSD) average symptom score at Week 12 (in patients with baseline CFS ≥ 1 or OSD score > 0, respectively). Results: Non-inferiority criteria for IOP-lowering were met. Least square (LS) mean (standard error [SE]) IOP change from baseline with preservative-free latanoprost eye drop emulsion (N = 193) versus preserved latanoprost (N = 193) at Week 12 was −8.8 (0.3) mmHg versus −8.2 (0.3) mmHg at peak (difference: −0.6 mmHg; nominal p = 0.023); −8.6 (0.2) mmHg versus −8.1 (0.3) mmHg at trough (difference: −0.5 mmHg; p = 0.080). LS mean change in CFS (SE) was −0.7 (0.07) with preservative-free latanoprost eye drop emulsion and −0.4 (0.08) with preserved latanoprost (nominal p < 0.001). LS mean change in OSD symptom score was −0.3 (0.1) with preservative-free latanoprost eye drop emulsion and −0.2 (0.1) with preserved latanoprost (nominal p = 0.090). Conclusions: Preservative-free latanoprost eye drop emulsion demonstrated non-inferior IOP-lowering efficacy compared with preserved latanoprost, and improved signs and symptoms of OSD.

Idioma: Inglés

DOI: 10.1038/s41433-025-03646-z

Año: 2025

Publicado en: Eye (Basingstoke) (2025), [9 pp.]
ISSN: 0950-222X

Tipo y forma: Article (Published version)

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