Abstract
Given that nonadherence is related to subject characteristics and drug tolerance and preserved eye drops tend to be more intolerable than preservative-free ones, we conducted a phase 4, parallel-grouped, investigator-blind, active-control, randomized, multicenter study. A total of 51 patients with intraocular pressure (IOP) ≥ 15 mmHg diagnosed with open-angle glaucoma or ocular hypertension were randomly assigned to the preserved latanoprost group (n = 26) and the preservative-free latanoprost group (n = 25). The efficacy variables were corneal/conjunctival staining grade, Ocular Surface Disease Index (OSDI), adherence at 12 weeks after the first administration; corneal/conjunctival staining grade at 4 weeks; and IOP, tear break-up time (TBUT), and hyperemia score at 4 and 12 weeks. The safety variables included visual acuity and drug tolerance questionnaire results. There was no statistically significant difference in corneal/conjunctival staining grade, OSDI, or TBUT between the groups at 4 and 12 weeks. However, the adherence rate was higher and the hyperemia score was lower in the preservative-free group than in the preserved group. The severity and duration of stinging/burning sensation were lower in the preservative-free group than in the preserved group. Overall, preservative-free latanoprost showed better ocular tolerance assessed by hyperemia scores and stinging/burning symptoms following higher adherence than preserved latanoprost.
Highlights
Given that nonadherence is related to subject characteristics and drug tolerance and preserved eye drops tend to be more intolerable than preservative-free ones, we conducted a phase 4, parallelgrouped, investigator-blind, active-control, randomized, multicenter study
Since the main strategy for treating glaucoma is adequate control of intraocular pressure (IOP) using antiglaucoma eye drops, physicians have been focused on how patients become more adherent to eye drop usage
A large number of glaucoma patients experience ocular symptoms and signs upon and between instillation of antiglaucoma eye drops, which can affect the quality of life and adherence to therapy[2,3,4]
Summary
Given that nonadherence is related to subject characteristics and drug tolerance and preserved eye drops tend to be more intolerable than preservative-free ones, we conducted a phase 4, parallelgrouped, investigator-blind, active-control, randomized, multicenter study. Preservative-free latanoprost showed better ocular tolerance assessed by hyperemia scores and stinging/burning symptoms following higher adherence than preserved latanoprost. A large number of glaucoma patients experience ocular symptoms and signs upon and between instillation of antiglaucoma eye drops, which can affect the quality of life and adherence to therapy[2,3,4]. A study by Misiuk-Hojlo et al showed that the rate of moderate-to-severe conjunctival hyperemia and subjective ocular symptoms were less likely to be seen during the 3-month follow-up after switching from preserved latanoprost to preservative-free latanoprost[8]. To the best of our knowledge, this is the first prospective parallelgrouped study that directly compared the ocular signs, symptoms, and adherence between the preserved and preservative-free latanoprost groups
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