The effects of topical oxymetazoline on eyelid position, eye redness, and patient-reported eye appearance: A randomized controlled 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
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

66-74

Informations 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.

Auteurs

Marissa K Shoji (MK)

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, FL, United States of America.

Zahra Markatia (Z)

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, FL, United States of America.

Kambiz Ameli (K)

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, FL, United States of America.

Mandah Bayaraa (M)

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, FL, United States of America.

Kevin D Clauss (KD)

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, FL, United States of America.

Shoaib Ugradar (S)

Department of Ophthalmology, Jules Stein Eye Institute, University of California Los Angeles, Los Angeles, CA, United States of America.

Wendy W Lee (WW)

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, FL, United States of America. Electronic address: wlee@med.miami.edu.

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Classifications MeSH