Busca avançada
Ano de início
Entree


Insulin Nanoemulsion Eye Drops for the Treatment of Dry Eye Disease in Sjögren's Disease: A Randomized Clinical Trial Phase I/II

Texto completo
Autor(es):
Marzola, Mateus Maia ; Gutierrez, Diego Rocha ; Cintra, Beatriz Carneiro ; Murashima, Adriana de Andrade Batista ; Dalmolin, Luciana Facco ; Garcia, Denny Marcos ; Lopez, Renata Fonseca Vianna ; Oliveira, Fabiola Reis ; Rocha, Eduardo Melani
Número total de Autores: 9
Tipo de documento: Artigo Científico
Fonte: VISION; v. 9, n. 3, p. 12-pg., 2025-07-09.
Resumo

Dry eye disease (DED) is a hallmark of primary Sj & ouml;gren's disease (SjD) and often resists conventional treatments like lubricant eye drops. Insulin nanoemulsions offer a potential solution by improving drug penetration and retention on the ocular surface. In animal models, insulin has shown benefits in promoting tear secretion and corneal healing. This study evaluated the safety and efficacy of insulin nanoemulsion eye drops (20 IU/mL, three times daily for 30 days) in patients with SjD. Thirty-two patients were randomized in a double-masked design to receive either insulin or placebo drops. Symptoms (assessed by OSDI questionnaire) and objective measures (tear film breakup time, corneal and conjunctival staining, and Schirmer Test) were recorded at baseline, after 4 weeks of treatment, and at a 4-week follow-up. Twenty-three participants completed the study. Both groups showed significant improvement in symptoms and objective signs after treatment (p < 0.05), but no significant differences were found between the insulin and placebo groups. No clinically relevant adverse effects were reported. Insulin nanoemulsion eye drops are safe for SjD patients, but their therapeutic advantage remains unclear. Further studies with larger samples, extended follow-up, and dose adjustments are needed to better understand their potential. (AU)

Processo FAPESP: 22/03521-0 - Investigação de métodos físicos associados à sistemas de liberação de fármacos na resposta imune e antimicrobiana local
Beneficiário:Renata Fonseca Vianna Lopez
Modalidade de apoio: Auxílio à Pesquisa - Temático
Processo FAPESP: 22/12312-6 - Estudo clínico comparativo de colírio com nanoemulsão contendo insulina ou canabidiol para o tratamento de lesão ocular por doenças do olho seco.
Beneficiário:Mateus Maia Marzola
Modalidade de apoio: Bolsas no Brasil - Iniciação Científica
Processo FAPESP: 21/07312-4 - Papel dos desreguladores endócrinos nas manifestações clínicas e neurológicas na Síndrome de Sjögren e eficácia das nanodispersões lipídicas de insulina e canabidiol para o tratamento do olho seco
Beneficiário:Eduardo Melani Rocha
Modalidade de apoio: Auxílio à Pesquisa - Regular