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

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 pati

SUBMITTER: Baudouin C 

PROVIDER: S-EPMC12089586 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature