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Background/Objectives <p>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).</p> Methods <p>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 &gt; 0, respectively).</p> Results <p>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 &lt; 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).</p> Conclusions <p>Preservative-free latanoprost eye drop emulsion demonstrated non-inferior IOP-lowering efficacy compared with preserved latanoprost, and improved signs and symptoms of OSD.</p>

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

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  • 发表日期：

    2025年2月25日

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

摘要

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.