Efficacy and Safety of a Cationic Emulsion in the Treatment of Moderate to Severe Dry Eye Disease: A Randomized Controlled Study

Robert, Pierre-Yves; Cochener, Béatrice; Amrane, Mourad; Ismail, Dahlia; Garrigue, Jean-Sébastien; Pisella, Pierre‐Jean; Baudouin, Christophe

doi:10.5301/ejo.5000830

Cited by 34 publications

(58 citation statements)

References 37 publications

(43 reference statements)

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“…This fundamental surface chemistry and in silico molecular dynamics simulations research on CEs and their molecular components (polar lipids and hydrophilic surface-active excipients) explain from a mechanistic physicochemical point of view the improvement in TF break-up time observed in clinical trials, for both the CE ATs 10,34 and CE drug products. 11,35 In addition, a comparison of CE versus a polyvinyl alcohol and povidone-based lubricant demonstrated that a statistically significant improvement in tear break-up time was observed on day 28 (+2.0 vs. +0.5 s; P = 0.0349) in MGD patients treated with the CE, hence confirming that the CE may act on the TF stability.…”

Section: Improved Tf Stability With the Cesmentioning

confidence: 76%

“…Although it is the most hydrophobic subcomponent of the benzalkonium chloride (BAK) mixture-which explains its improved safety profile when formulated in emulsion 8,9,58-61 versus the benzyl alkyl quaternary ammoniums chloride with shorter aliphatic chains (12 or 14 carbons) 8,9 -it was not anticipated that CKC, through its modulation of PKCa, could be even partly responsible for the good clinical performance of the CEs. 10,11,35 Indeed, Pflugfelder and collaborators demonstrated in a PKCa knock-out mouse the benefits that PKCa ''inhibition'' has on corneal inflammation and its healing process. 62 When formulated in CEs, CKC does not harbor any of the detrimental side effects of the shorter BAK quaternary ammonium compounds, but instead offers the benefits of modulating PKCa for the management of inflammation and the improvement of wound-healing processes in DE patients in addition to mechanically stabilizing the TFLL.…”

Section: Reduced Hyperosmolarity and Its Associated Cellular Stress Wmentioning

confidence: 99%

“…Cationic emulsion (CE)-based artificial tear (AT) eye drops 8 , 9 have recently developed lipid-containing ATs (Cationorm ® , Cationorm Pro, Santen) 10 that besides CE-based drug carriers (Ikervis ® , Santen) 11 , 12 have been designed for the management of the clinical signs and symptoms of DED as well as the management of vernal keratoconjunctivitis in children (Verkazia ® , Santen). 13 The present review compiles and discusses the findings from extended in silico , in vitro , and in vivo studies of CEs.…”

Section: The Cationic Emulsions For Dry Eye Managementmentioning

confidence: 99%

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Cationic Emulsion-Based Artificial Tears as a Mimic of Functional Healthy Tear Film for Restoration of Ocular Surface Homeostasis in Dry Eye Disease

Daull

Amrane

Ismail

et al. 2020

Journal of Ocular Pharmacology and Therapeutics

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Dry eye disease (DED) is a complex multifactorial disease that affects an increasing number of patients worldwide. Close to 30% of the population has experienced dry eye (DE) symptoms and presented with some signs of the disease during their lifetime. The significant heterogeneity in the medical background of patients with DEs and in their sensitivity to symptoms renders a clear understanding of DED complicated. It has become evident over the past few years that DED results from an impairment of the ocular surface homeostasis. Hence, a holistic treatment approach that concomitantly addresses the different mechanisms that result in the destabilization of the tear film (TF) and the ocular surface would be appropriate. The goal of the present review is to compile the different types of scientific evidence (from in silico modeling to clinical trials) that help explain the mechanism of action of cationic emulsion (CE)-based eye drop technology for the treatment of both the signs and the symptoms of DED. These CEbased artificial tear (AT) eye drops designed to mimic, from a functional point of view, a healthy TF contribute to the restoration of a healthy ocular surface environment and TF that leads to a better management of DE patients. The CE-based AT eye drops help restore the ocular surface homeostasis in patients who have unstable TF or no tears.

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Section: Improved Tf Stability With the Cesmentioning

confidence: 76%

Section: Reduced Hyperosmolarity and Its Associated Cellular Stress Wmentioning

confidence: 99%

Section: The Cationic Emulsions For Dry Eye Managementmentioning

confidence: 99%

See 1 more Smart Citation

Cationic Emulsion-Based Artificial Tears as a Mimic of Functional Healthy Tear Film for Restoration of Ocular Surface Homeostasis in Dry Eye Disease

Daull

Amrane

Ismail

et al. 2020

Journal of Ocular Pharmacology and Therapeutics

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“… 84 In another clinical trial of Cationorm and Vismed ® (TRB Chemedica) in patients with moderate-to-severe dry eye, although both eye drops showed similar safety profiles and efficacy in terms of improvements in objective signs of dry eye, Cationorm was superior in improving the global symptoms score of ocular discomfort. 85 …”

Section: Lipid-based Therapiesmentioning

confidence: 99%

Relevance of Lipid-Based Products in the Management of Dry Eye Disease

Garrigue

Amrane

Faure

et al. 2017

Journal of Ocular Pharmacology and Therapeutics

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Components of the ocular surface synergistically contribute to maintaining and protecting a smooth refractive layer to facilitate the optimal transmission of light. At the air–water interface, the tear film lipid layer (TFLL), a mixture of lipids and proteins, plays a key role in tear surface tension and is important for the physiological hydration of the ocular surface and for ocular homeostasis. Alterations in tear fluid rheology, differences in lipid composition, or downregulation of specific tear proteins are found in most types of ocular surface disease, including dry eye disease (DED). Artificial tears have long been a first line of treatment in DED and aim to replace or supplement tears. More recently, lipid-containing eye drops have been developed to more closely mimic the combination of aqueous and lipid layers of the TFLL. Over the last 2 decades, our understanding of the nature and importance of lipids in the tear film in health and disease has increased substantially. The aim of this article is to provide a brief overview of our current understanding of tear film properties and review the effectiveness of lipid-based products in the treatment of DED. Liposome lid sprays, emulsion eye drops, and other lipid-containing formulations are discussed.

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“…Cationorm ® (CN) cationic nanoemulsion (see Section 4.1 for CN composition) was shown to enhance tear film stability at the ocular surface possibly via effect on tear film lipid layer (TFLL) [ 23 , 24 ]. Thus the impact of CN on human meibum and TFLL in vitro and in vivo have to be studied in detail.…”

Section: Introductionmentioning

confidence: 99%

Surface Chemistry Interactions of Cationorm with Films by Human Meibum and Tear Film Compounds

Georgiev

Yokoi

Nencheva

et al. 2017

IJMS

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Cationorm® (CN) cationic nanoemulsion was demonstrated to enhance tear film (TF) stability in vivo possibly via effects on tear film lipid layer (TFLL). Therefore the interactions of CN with human meibum (MGS) and TFLL in vitro and in vivo deserve special study. MGS and CN were spread at the air/water interface of a Langmuir surface balance to ensure a range of MGS/CN oil phase ratios: 20/1, 10/1, 5/1, 3/1, 2/1 and 1/1. The films capability to reorganize during dynamic area changes was evaluated via the surface pressure-area compression isotherms and step/relaxation dilatational rheology studies. Films structure was monitored with Brewster angle microscopy. CN/TFLL interactions at the ocular surface were monitored with non-contact specular microscopy. The in vitro studies of MGS/CN layers showed that (i) CN inclusion (at fixed MGS content) increased film elasticity and thickness and that (ii) CN can compensate for moderate meibum deficiency in MGS/CN films. In vivo CN mixed with TFLL in a manner similar to CN/MGS interactions in vitro, and resulted in enhanced thickness of TFLL. In vitro and in vivo data complement each other and facilitated the study of the composition-structure-function relationship that determines the impact of cationic nanoemulsions on TF.

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Efficacy and Safety of a Cationic Emulsion in the Treatment of Moderate to Severe Dry Eye Disease: A Randomized Controlled Study

Abstract: CE was similar to HS with regards to safety and efficacy for objective signs but was superior to HS in improving DED symptoms in patients with moderate to severe DED.

Cited by 34 publications

References 37 publications

Cationic Emulsion-Based Artificial Tears as a Mimic of Functional Healthy Tear Film for Restoration of Ocular Surface Homeostasis in Dry Eye Disease

Cationic Emulsion-Based Artificial Tears as a Mimic of Functional Healthy Tear Film for Restoration of Ocular Surface Homeostasis in Dry Eye Disease

Relevance of Lipid-Based Products in the Management of Dry Eye Disease

Surface Chemistry Interactions of Cationorm with Films by Human Meibum and Tear Film Compounds

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