Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye

<b>Background</b>: Dry eye disease (DED) is currently recognized as a global health concern, with a prevalence that ranges from 5% to 75%. Given the severity of dry eye in diabetic patients and the global prevalence of diabetes, it is crucial to evaluate new treatments that potentially i...

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Main Authors: Rosario Gulias-Cañizo, Pablo Alexis Limón-Zurita, Jimena Ceja-Martínez, Oscar Guerrero-Berger
Format: Article
Language:English
Published: MDPI AG 2025-03-01
Series:Biomedicines
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Online Access:https://www.mdpi.com/2227-9059/13/4/763
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author Rosario Gulias-Cañizo
Pablo Alexis Limón-Zurita
Jimena Ceja-Martínez
Oscar Guerrero-Berger
author_facet Rosario Gulias-Cañizo
Pablo Alexis Limón-Zurita
Jimena Ceja-Martínez
Oscar Guerrero-Berger
author_sort Rosario Gulias-Cañizo
collection DOAJ
description <b>Background</b>: Dry eye disease (DED) is currently recognized as a global health concern, with a prevalence that ranges from 5% to 75%. Given the severity of dry eye in diabetic patients and the global prevalence of diabetes, it is crucial to evaluate new treatments that potentially improve tear film stability in this patient population. <b>Methods</b>: Single-center, open-label, single-arm, and interventional study in adult patients with type-2 diabetes mellitus and all DED subtypes evaluating a propylene glycol-hydroxypropyl guar nanoemulsion that has shown in previous studies to improve tear film stability in nondiabetic patients. <b>Results</b>: After 28 days of treatment, the Ocular Surface Disease Index (OSDI) scores showed significant improvement, decreasing from a baseline mean of 42.72 ± 17.69 to 25.53 ± 17.14 on Day 28 (<i>p</i> < 0.001); Non-Invasive Keratograph Break-Up Time (NIKBUT) also improved significantly, increasing from 3.45 ± 1.17 s at baseline to 5.94 ± 1.48 s on Day 28 (<i>p</i> < 0.001). No significant changes were observed in the infrared meibography score (baseline: 1.48 ± 0.93 vs. Day 28: 1.47 ± 0.92, <i>p</i> = 0.279), tear meniscus height (TMH) (baseline: 0.25 ± 0.10 mm vs. Day 28: 0.25 ± 0.08 mm, <i>p</i> = 0.086), or meibomian gland expressibility score (MGES). The redness score significantly decreased from 1.88 ± 0.68 at baseline to 1.40 ± 0.59 on Day 28 (<i>p</i> < 0.001). <b>Conclusions</b>: These findings suggest notable improvements in both signs and symptoms of dry eye disease in diabetic patients with all DED subtypes and severity categories.
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spelling doaj-art-b73d6d5e5c3744de937bd5f7bb99d4822025-08-20T02:24:44ZengMDPI AGBiomedicines2227-90592025-03-0113476310.3390/biomedicines13040763Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry EyeRosario Gulias-Cañizo0Pablo Alexis Limón-Zurita1Jimena Ceja-Martínez2Oscar Guerrero-Berger3Clinical Research, Fundación Hospital Nuestra Señora de la Luz, Mexico City 06030, MexicoDepartment of Anterior Segment Surgery, Fundación Hospital Nuestra Señora de la Luz, Ezequiel Montes 135, Tabacalera, Cuauhtémoc, Mexico City 06030, MexicoDepartment of Anterior Segment Surgery, Fundación Hospital Nuestra Señora de la Luz, Ezequiel Montes 135, Tabacalera, Cuauhtémoc, Mexico City 06030, MexicoCentro Oftalmológico Mira, Taxco 35, Roma Sur, Cuauhtémoc, Mexico City 03840, Mexico<b>Background</b>: Dry eye disease (DED) is currently recognized as a global health concern, with a prevalence that ranges from 5% to 75%. Given the severity of dry eye in diabetic patients and the global prevalence of diabetes, it is crucial to evaluate new treatments that potentially improve tear film stability in this patient population. <b>Methods</b>: Single-center, open-label, single-arm, and interventional study in adult patients with type-2 diabetes mellitus and all DED subtypes evaluating a propylene glycol-hydroxypropyl guar nanoemulsion that has shown in previous studies to improve tear film stability in nondiabetic patients. <b>Results</b>: After 28 days of treatment, the Ocular Surface Disease Index (OSDI) scores showed significant improvement, decreasing from a baseline mean of 42.72 ± 17.69 to 25.53 ± 17.14 on Day 28 (<i>p</i> < 0.001); Non-Invasive Keratograph Break-Up Time (NIKBUT) also improved significantly, increasing from 3.45 ± 1.17 s at baseline to 5.94 ± 1.48 s on Day 28 (<i>p</i> < 0.001). No significant changes were observed in the infrared meibography score (baseline: 1.48 ± 0.93 vs. Day 28: 1.47 ± 0.92, <i>p</i> = 0.279), tear meniscus height (TMH) (baseline: 0.25 ± 0.10 mm vs. Day 28: 0.25 ± 0.08 mm, <i>p</i> = 0.086), or meibomian gland expressibility score (MGES). The redness score significantly decreased from 1.88 ± 0.68 at baseline to 1.40 ± 0.59 on Day 28 (<i>p</i> < 0.001). <b>Conclusions</b>: These findings suggest notable improvements in both signs and symptoms of dry eye disease in diabetic patients with all DED subtypes and severity categories.https://www.mdpi.com/2227-9059/13/4/763dry eyeOSDIocular surface disease indexnon-invasive keratograph break-up timeNIKBUTNIBUT
spellingShingle Rosario Gulias-Cañizo
Pablo Alexis Limón-Zurita
Jimena Ceja-Martínez
Oscar Guerrero-Berger
Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye
Biomedicines
dry eye
OSDI
ocular surface disease index
non-invasive keratograph break-up time
NIKBUT
NIBUT
title Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye
title_full Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye
title_fullStr Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye
title_full_unstemmed Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye
title_short Effect of a Nano-Sized Lipid-Based Eye Drop on Diabetic Dry Eye
title_sort effect of a nano sized lipid based eye drop on diabetic dry eye
topic dry eye
OSDI
ocular surface disease index
non-invasive keratograph break-up time
NIKBUT
NIBUT
url https://www.mdpi.com/2227-9059/13/4/763
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AT oscarguerreroberger effectofananosizedlipidbasedeyedropondiabeticdryeye