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.
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; Null, Null; 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; 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. - In: EYE. - ISSN 0950-222X. - 39:8(2025), pp. 1599-1607. [10.1038/s41433-025-03646-z]
A phase III study comparing preservative-free latanoprost eye drop emulsion with preserved latanoprost in open-angle glaucoma or ocular hypertension
Manni, Gianluca;Leonardi, Andrea;
2025
Abstract
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.| File | Dimensione | Formato | |
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