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

IF 2.8 3区医学 Q1 OPHTHALMOLOGY

Eye Pub Date : 2025-02-25 DOI:10.1038/s41433-025-03646-z

Christophe Baudouin, Ingeborg Stalmans, Rupert Bourne, Jose Manuel Larrosa, Stefanie Schmickler, Aleksey Seleznev, Francesco Oddone

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引用次数: 0

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.

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来源期刊

Eye 医学-眼科学

CiteScore

6.40

自引率

5.10%

发文量

481

审稿时长

3-6 weeks

期刊介绍： Eye seeks to provide the international practising ophthalmologist with high quality articles, of academic rigour, on the latest global clinical and laboratory based research. Its core aim is to advance the science and practice of ophthalmology with the latest clinical- and scientific-based research. Whilst principally aimed at the practising clinician, the journal contains material of interest to a wider readership including optometrists, orthoptists, other health care professionals and research workers in all aspects of the field of visual science worldwide. Eye is the official journal of The Royal College of Ophthalmologists. Eye encourages the submission of original articles covering all aspects of ophthalmology including: external eye disease; oculo-plastic surgery; orbital and lacrimal disease; ocular surface and corneal disorders; paediatric ophthalmology and strabismus; glaucoma; medical and surgical retina; neuro-ophthalmology; cataract and refractive surgery; ocular oncology; ophthalmic pathology; ophthalmic genetics.