[Unpreserved latanoprost in the treatment of open-angle glaucoma and ocular hypertension. A multicenter, randomized, controlled study].

Objectives: To evaluate the safety and efficacy of unpreserved latanoprost eye drops (UNL) in comparison with preserved latanoprost eye drops (LBAK) in patients with glaucoma or ocular hypertension stabilized with preserved latanoprost eye drops as monotherapy.
Methods: Multicenter, randomized, open, two-parallel group study. The intraocular pressure (IOP), ocular signs and symptoms, adverse events and a quality of life questionnaire were evaluated at inclusion (D0) and after 3 months of treatment (D84).
Results: One hundred and eighty-three patients were evaluated (38.7 % with an ocular hypertension and 61.3 % with open-angle glaucoma): 130 in the UNL group and 53 in the LBAK group). In the UNL group, mean IOP remained unchanged after 3 months of treatment and the mean difference with LBAK was 0.503mmHg with a confidence interval between -0.202 and 1.208, establishing non-inferiority of UN-L versus BAK-L. Overall, the total score of conjunctival hyperemia improved to a greater extent in the UNL group (-0.5±0.8) compared to the LBAK group (-0.1±0.6, P=0.0004), as well as the total score of symptoms on instillation (-2.0±2.7 versus -0.9±2.2, P=0.0035), and between instillations (-1.8±2.8 vs. -0.3±1.3, P=0.0003).
Conclusion: The results of this study showed that preserved latanoprost eye drops may be substituted with unpreserved latanoprost eye drops with better tolerability in glaucoma patients with stable IOP.
(Copyright © 2016 Elsevier Masson SAS. All rights reserved.)