Physicochemical characterization of a DMPC-based nanoemulsion for dry eye and compatibility test with soft contact lenses in vitro

Chávez-Hurtado, Paulina; Pesqueda-Pinedo, Luciano; Ceballos-Delgadillo, Hector A; Liñán-Segura, Addy; Figueroa-Ponce, Humberto; Quintana-Hau, Juan D

doi:10.1016/j.clae.2021.02.014

Cited by 3 publications

(4 citation statements)

References 33 publications

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“…PRO-176 is a nanoemulsion that supplements lipids to the tear flm while maintaining aqueous-like dispersion over LGCS, lissamine green conjunctival staining; OSDI, ocular surface disease index; PP, per-protocol; SD, standard deviation; TBUT, tear break-up time. the ocular surface, both because of the small particles it contains and through the incorporation of propylene glycol in its formulation [9].…”

Section: Discussionmentioning

confidence: 99%

“…PRO-176 is a nanoemulsion that supplements lipids to the tear film while maintaining aqueous-like dispersion over the ocular surface, both because of the small particles it contains and through the incorporation of propylene glycol in its formulation [ 9 ].…”

Section: Discussionmentioning

confidence: 99%

“…This study evaluated the safety (phase I) and efficacy (phase II) of PRO-176, in comparison to the commercially available Systane Balance®. Following a complete pipeline of development, PRO-176 had already been subjected to a cytotoxicity preclinical evaluation in NHEK-Neo cells with satisfactory results [ 9 ]. On the other hand, during clinical evaluations, safety was measured during the phase I portion of this trial through the incidence of unexpected AE-related to the product.…”

Section: Discussionmentioning

confidence: 99%

“…The rheological properties of propylene glycol, a synthetic lubricant used in several commercially available eyedrops (some of which include lipids in their formulations), modify the tear film's viscosity while the lipidic phase of the nanoemulsion acts as a surfactant, aiding in the adequate dissemination of nonpolar lipids in the aqueous component of the tears. The resulting barrier between the aqueous and lipidic phases supports the nonpolar phase, decreasing the evaporation rate of the tear film [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of an Ophthalmic DMPC‐Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial

Baiza-Durán

Muñoz‐Villegas

Sánchez‐Ríos

et al. 2023

Journal of Ophthalmology

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Purpose. The goals of this study were to evaluate the safety and efficacy of an ophthalmic 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC)-based nanoemulsion (Nanodrop®) in patients with dry eye disease (DED). Methods. This was a randomized phase I/II multicentric, prospective, double-blind clinical trial. Patients (phase I: n = 25 and phase II: n = 101) were assigned to receive either PRO-176 (Nanodrop®) or Systane Balance® (control) for 29 days. Once the visits of the first 25 subjects were completed, if there were less than 20% of unexpected adverse events (AEs), related to PRO-176, recruitment was continued until the sample was completed for noninferiority (efficacy) analysis (phase II, n = 126). Efficacy endpoints were the ocular surface disease index (OSDI), tear break-up time (TBUT), epithelial defects, best corrected visual acuity (BCVA), and the incidence of expected AE. Results. For the phase I portion of the study, there were no differences between groups regarding the incidence of AE. All related-AE symptoms in both groups were mild and expected. For the phase II subset, there was a significant reduction in OSDI scores at day 29 and noninferiority between treatments was confirmed ( p = 0.650 , CI 95% [−8.7, 5.5]). Similar improvement was observed for TBUT although no significant intergroup differences were found ( p = 0.518 , CI 95% [−0.08, 1.6]). There were no significant differences between treatments for epithelial staining or safety parameters. Conclusions. Topical application of PRO-176 is as safe and effective as the controls. Both groups were clinically similar in terms of efficacy and safety. The results support the hypothesis that ophthalmic DMPC-based nanoemulsion may improve clinical parameters and symptoms in patients with DED. This trial is registered with NCT04111965.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of an Ophthalmic DMPC‐Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial

Baiza-Durán

Muñoz‐Villegas

Sánchez‐Ríos

et al. 2023

Journal of Ophthalmology

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A novel osmoprotective liposomal formulation from synthetic phospholipids to reducein vitrohyperosmolar stress in dry eye treatments

Casamayor

Cano

Guerrero

et al. 2022

Journal of Liposome Research

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Nanomedicines for Dry Eye Syndrome: Targeting Oxidative Stress with Modern Nanomaterial Strategies

Krawczyk,

Stadler,

Strzalka-Mrozik

2024

Molecules

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Dry eye syndrome (DES) is a dynamic, chronic disease of the ocular surface and ocular appendages caused by inflammation. The most common symptoms include redness, itching, and blurred vision, resulting from dysfunction of the meibomian glands and impaired tear-film production. Factors contributing to the development of DES include environmental elements, such as UV radiation, and internal elements, such as hormonal imbalances. These factors increase oxidative stress, which exacerbates inflammation on the surface of the eye and accelerates the development of DES. In recent years, the incidence of DES has risen, leading to a greater need to develop effective treatments. Current treatments for dry eye are limited and primarily focus on alleviating individual symptoms, such as reducing inflammation of the ocular surface. However, it is crucial to understand the pathomechanism of the disease and tailor treatment to address the underlying causes to achieve the best possible therapeutic outcomes. Therefore, in this review, we analyzed the impact of oxidative stress on the development of DES to gain a better understanding of its pathomechanism and examined recently developed nanosystems that allow drugs to be delivered directly to the disease site.

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Physicochemical characterization of a DMPC-based nanoemulsion for dry eye and compatibility test with soft contact lenses in vitro

Cited by 3 publications

References 33 publications

Efficacy and Safety of an Ophthalmic DMPC‐Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial

Efficacy and Safety of an Ophthalmic DMPC‐Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial

A novel osmoprotective liposomal formulation from synthetic phospholipids to reducein vitrohyperosmolar stress in dry eye treatments

Nanomedicines for Dry Eye Syndrome: Targeting Oxidative Stress with Modern Nanomaterial Strategies

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