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Clinical Trial
. 2025 Jun;39(8):1599-1607.
doi: 10.1038/s41433-025-03646-z. Epub 2025 Feb 25.

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

Christophe Baudouin  1   2 , Ingeborg Stalmans  3   4 , Rupert Bourne  5   6 , Jose Manuel Larrosa  7 , Stefanie Schmickler  8 , Aleksey Seleznev  9   10 , Francesco Oddone  11 ; Phase III study group
Collaborators, Affiliations
Clinical Trial

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

Christophe Baudouin et al. Eye (Lond). 2025 Jun.

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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Conflict of interest statement

Competing interests: Christophe Baudouin is a consultant for Alcon, Bausch & Lomb, Horus Pharma, Oculis, Santen and Théa. Ingeborg Stalmans received grant/research support from Théa and Santen, clinical trial participation from Théa and Santen, honoraria/consulting fees from Alcon, Allergan/AbbVie, Elios, EyeD, Horus, Santen and Théa, and investments (stock options etc.) from Mona. Rupert Bourne received grant/research support from Théa, Santen, GSK and Allergan/AbbVie. Jose Manuel Larrosa received consulting and speaker fees from Allergan/AbbVie, Bausch & Lomb and Johnson & Johnson. Stefanie Schmickler received honoraria/consulting fees from Bayer, Johnson & Johnson, Kowa, Rayner, and Ziemer and clinical trial fees from Santen. Francesco Oddone is a consultant for AbbVie, Santen, Omikron Italia, Sooft and Théa; received speaker fees from Santen and Omikron Italia, Théa and Aerie; and grants from AbbVie, Santen and Omikron Italia. Aleksey Seleznev has no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1. Mean IOP change from baseline in the efficacy population.
IOP intraocular pressure, LS least square, SD standard deviation, SE standard error.
Fig. 2
Fig. 2. Mean diurnal IOP change at Week 12 in the efficacy population.
IOP intraocular pressure, SD standard deviation, SE standard error.
Fig. 3
Fig. 3. Mean change from baseline in CFS and OSD scores at Weeks 4 and 12 in patients with baseline CFS ≥1 or OSD score>0.
Mean change in CFS (A) and OSD (B) scores in patients with baseline CFS ≥ 1 or OSD score >0 at Weeks 4 and 12. CFS corneal fluorescein staining, LS least square, OSD ocular surface disease, SD standard deviation, SE standard error.
See this image and copyright information in PMC

References

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