Comparison of ocular surface assessment and adherence between preserved and preservative-free latanoprost in glaucoma: a parallel-grouped randomized trial

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 i...

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Bibliographic Details
Published in:Scientific reports 2021-07, Vol.11 (1), p.14971-14971, Article 14971
Main Authors: Kim, Dai Woo, Shin, Jonghoon, Lee, Chang Kyu, Kim, Myungjin, Lee, Sohyeon, Rho, Seungsoo
Format: Article
Language:English
Subjects:
692/308/2779/777
692/699/3161/3169/3170
Acuity
Burning
Cornea
Drug tolerance
Glaucoma
Humanities and Social Sciences
Hyperemia
Hypertension
multidisciplinary
Preservatives
Science
Science (multidisciplinary)
Statistical analysis
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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, 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.
ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-021-94574-x