Trial reportEye (London, England)2025
A phase III study comparing preservative-free latanoprost eye drop emulsion with preserved latanoprost in open-angle glaucoma or ocular hypertension.
Trial report in Eye (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Fifteen-Month Outcomes of Preservative-Free Latanoprost Cationic Emulsion in Open-Angle Glaucoma and Ocular Hypertension: Phase III Open-Label Extension of a Randomized Trial.Clinical ophthalmology (Auckland, N.Z.) · 2025Trial
- Nanoformulations for Ocular Drug Delivery in Glaucoma: From Metal-Based Nanoparticles to Advanced Nanocarriers.Pharmaceutics · 2026Review
- Improved de novo production of prostaglandin FCommunications biology · 2026Article
- Optimizing Ocular Surface Disease (OSD) Management in Patients with Glaucoma: Expert Strategies from Asia.Clinical ophthalmology (Auckland, N.Z.) · 2026Article
- Impact of Preservative-Free Travoprost on Intraocular Pressure and Ocular Surface in Primary Open-Angle Glaucoma Patients.Life (Basel, Switzerland) · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectivesTo 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).
methodsA 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).
resultsNon-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).
conclusionsPreservative-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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