The effects of topical oxymetazoline on eyelid position, eye redness, and patient-reported eye appearance: A randomized controlled trial.
Esthetics
Eye appearance
Eye redness
Eyelid position
Oxymetazoline
Randomized clinical trial
Journal
Journal of plastic, reconstructive & aesthetic surgery : JPRAS
ISSN: 1878-0539
Titre abrégé: J Plast Reconstr Aesthet Surg
Pays: Netherlands
ID NLM: 101264239
Informations de publication
Date de publication:
05 2023
05 2023
Historique:
received:
10
08
2022
revised:
02
02
2023
accepted:
03
02
2023
medline:
2
5
2023
pubmed:
31
3
2023
entrez:
30
3
2023
Statut:
ppublish
Résumé
This study assesses the effects of topical oxymetazoline 0.1% on eyelid position, eye redness, and patient-perceived eye appearance in patients without severe ptosis. This is a randomized double-blinded controlled trial conducted at a single institute. Patients aged 18-100 years were randomized to receive one drop of oxymetazoline hydrochloride 0.1% or placebo bilaterally. Marginal reflex distance (MRD) 1 and 2, palpebral fissure height, eye redness, and patient-perceived eye appearance were assessed at baseline and two hours after drop instillation. Primary outcome measures included the change in MRD1, MRD2, and palpebral fissure height. Secondary outcome measures included changes in eye redness and patient-perceived eye appearance after drop instillation. In total, 114 patients were included, 57 treatment patients (mean age 36.4 ± 12.7 years, 31.6% male) and 57 controls (mean age 31.3 ± 10.1 years, 33.3% male). Baseline mean MRD1, MRD2, and palpebral fissure were similar between groups (p = 0.24, 0.45, and 0.23, respectively). Changes in MRD1 and eye redness in the treatment group were significantly greater than those in the control group (0.9 ± 0.9 mm vs. - 0.3 ± 0.4 mm, p < 0.001; - 2.6 ± 4.4 vs. - 0.5 ± 2.3, p = 0.002, respectively). Patient-perceived eye appearance was significantly improved in the treatment group compared to the controls (p = 0.002), with more treatment group patients also reporting increased eye size and decreased eye redness (p = 0.008, p = 0.003, respectively). There were 9 treatment-emergent adverse events (TEAEs) in 7 treatment group patients and 5 TEAEs in 5 control patients (p = 0.25), all of which were mild in severity. Topical oxymetazoline 0.1% increases MRD1 and palpebral fissure height, decreases eye redness, and improves patient-perceived eye appearance.
Identifiants
pubmed: 36996503
pii: S1748-6815(23)00059-1
doi: 10.1016/j.bjps.2023.02.006
pii:
doi:
Substances chimiques
Oxymetazoline
8VLN5B44ZY
Banques de données
ClinicalTrials.gov
['NCT04831047']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
66-74Informations de copyright
Copyright © 2023 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of Interest WWL is a consultant for Allergan, Galderma, Revance, Evolus, RVL, Horizon Therapeutics, Mallinckrodt, Tarsus and Solta. The following authors have no relevant financial disclosures or conflicts of interest: MKS, ZM, KA, EB, KDC, and SU.