000151490 001__ 151490
000151490 005__ 20250310131044.0
000151490 0247_ $$2doi$$a10.1038/s41433-025-03646-z
000151490 0248_ $$2sideral$$a143145
000151490 037__ $$aART-2025-143145
000151490 041__ $$aeng
000151490 100__ $$aBaudouin, Christophe
000151490 245__ $$aA phase III study comparing preservative-free latanoprost eye drop emulsion with preserved latanoprost in open-angle glaucoma or ocular hypertension
000151490 260__ $$c2025
000151490 5060_ $$aAccess copy available to the general public$$fUnrestricted
000151490 5203_ $$aBackground/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.
000151490 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000151490 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000151490 700__ $$aStalmans, Ingeborg
000151490 700__ $$aBourne, Rupert
000151490 700__ $$aLarrosa, Jose Manuel
000151490 700__ $$aSchmickler, Stefanie
000151490 700__ $$aSeleznev, Aleksey
000151490 700__ $$aOddone, Francesco
000151490 700__ $$aEl-Shabrawi, Yosuf
000151490 700__ $$aGarhoefer, Gerhard
000151490 700__ $$aMossboeck, Georg
000151490 700__ $$aStalmans, Ingeborg
000151490 700__ $$aKaljurand, Kuldar
000151490 700__ $$aNoor, Kai
000151490 700__ $$aJugaste, Tia
000151490 700__ $$aKaarniranta, Kai
000151490 700__ $$aBaudouin, Christophe
000151490 700__ $$aSantiago, Pierre Yves
000151490 700__ $$aLabetoulle, Marc
000151490 700__ $$aSchweitzer, Cedric
000151490 700__ $$aVabres, Bertand
000151490 700__ $$aLorenz, Katrin
000151490 700__ $$aSchuart, Claudia
000151490 700__ $$aSpitzer, Martin
000151490 700__ $$aHamacher, Thomas
000151490 700__ $$aSchmickler, Stefanie
000151490 700__ $$aThelen, Ulrich
000151490 700__ $$aOddone, Franceso
000151490 700__ $$aBarabino, Stefano
000151490 700__ $$aManni, Gianluca
000151490 700__ $$aLeonardi, Andrea
000151490 700__ $$aRossi, Gemma Caterina Maria
000151490 700__ $$aLanzetta, Paolo
000151490 700__ $$aBaumane, Kristine
000151490 700__ $$aLagnovska, Guna
000151490 700__ $$aGrundmane, Iveta
000151490 700__ $$aRekas, Marek
000151490 700__ $$aSiewierska, Malgorzata
000151490 700__ $$aMrukwa-Kominek, Ewa
000151490 700__ $$aFryczkowski, Piotr
000151490 700__ $$aMalyugin, Boris
000151490 700__ $$aLebedev, Oleg Ivanovich
000151490 700__ $$aBratko, Galina
000151490 700__ $$aAstakhov, Turiy Sergeevich
000151490 700__ $$aBoiko, Ernest Vitalyevich
000151490 700__ $$aAbduleva, Elmira
000151490 700__ $$aGavrilova, Natalia Aleksandrovna
000151490 700__ $$aGornostaeva, Ekaterina
000151490 700__ $$aSeleznev, Aleksey
000151490 700__ $$aPozdeeva, Nadezhda
000151490 700__ $$aMolokov, Kirill
000151490 700__ $$aKim, Chan Yun
000151490 700__ $$aPark, Ki Ho
000151490 700__ $$aPark, Chan Kee
000151490 700__ $$aBelda, Jose I.
000151490 700__ $$aLopez, Fernando Lopez
000151490 700__ $$0(orcid)0000-0002-6745-7668$$aLarrosa, José Manuel$$uUniversidad de Zaragoza
000151490 700__ $$aFeijóo, Julián García
000151490 700__ $$aPazos, Marta
000151490 700__ $$aMorena-Montañes, Javier
000151490 700__ $$aCalvo, Pedro Pablo Rodriguez
000151490 700__ $$aCanut, Maria Isabel
000151490 700__ $$aLópez, Alfonso Antón
000151490 700__ $$aHanspal, Inderraj
000151490 700__ $$aBourne, Rupert
000151490 700__ $$aKirwan, James
000151490 700__ $$aCordeiro, Francesca
000151490 7102_ $$11013$$2646$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Oftalmología
000151490 773__ $$g(2025), [9 pp.]$$pEye$$tEye (Basingstoke)$$x0950-222X
000151490 8564_ $$s2802395$$uhttps://zaguan.unizar.es/record/151490/files/texto_completo.pdf$$yVersión publicada
000151490 8564_ $$s2868835$$uhttps://zaguan.unizar.es/record/151490/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000151490 909CO $$ooai:zaguan.unizar.es:151490$$particulos$$pdriver
000151490 951__ $$a2025-03-10-12:56:52
000151490 980__ $$aARTICLE