Clinical efficacy of 0.05% cyclosporine nano-emulsion in the treatment of dry eye syndrome associated with meibomian gland dysfunction.

AIM To evaluate the clinical efficacy of topical 0.05% cyclosporine nano-emulsion in the treatment of dry eye syndrome (DES) with meibomian gland dysfunction (MGD). METHODS This prospective study included 64 patients with DES and MGD who were randomly assigned to three groups: Group 1 (n=24, conventional cyclosporine), Group 2 (n=21, nano-emulsion cyclosporine), and Group 3 (n=19, control). Lid margin telangiectasia (LMT), meibomian gland secretion (MGS), conjunctival injection (CI), corneal staining (CS), tear break-up time (TBUT), Schirmer test I (STI), Ocular Surface Disease Index (OSDI), and lipid layer thickness (LLT) was evaluated at 4, 8, and 12wk of treatment. RESULTS In Group 3 (control), LMT, CS, and CI improved after 8wk, MGS, TBUT after 12wk of treatment. In Group 1 (conventional cyclosporine), LMT, MGS, and TBUT improved significantly after 4wk, whereas CS, CI, STI, and LLT improved significantly after 8wk, and OSDI at 12wk. In Group 2 (nano-cyclosporine), LMT, MGS, CS, CI, TBUT, and OSDI significantly improved after 4wk, and STI after 8wk. Especially, LLT was significantly higher than other groups after 4wk. CONCLUSION Cyclosporine and nano-cyclosporine shows significant improvement in DES with MGD than the control group. In contrast, the nano-cyclosporine group shows more statistically improved CI and CS at 4wk, especially LLT at 4, 8, and 12wk compared to the conventional cyclosporine group.

[1]  J. Wolffsohn,et al.  Clinical practice patterns in the management of dry eye disease: A TFOS international survey. , 2021, The ocular surface.

[2]  M. Jabbari Nooghabi,et al.  Comparison of the effect of Tea tree oil shampoo with regular-lid shampoo in meibomian gland dysfunction treatment. , 2021, American journal of ophthalmology-glaucoma.

[3]  Jonghoon Shin,et al.  Efficacy of 0.05% cyclosporine A on the lipid layer and meibomian glands after cataract surgery: A randomized, double-masked study. , 2021, PloS one.

[4]  P. Karpecki,et al.  A Review of the Mechanism of Action of Cyclosporine A: The Role of Cyclosporine A in Dry Eye Disease and Recent Formulation Developments , 2020, Clinical ophthalmology.

[5]  L. Marelli,et al.  Latest evidences on meibomian gland dysfunction diagnosis and management. , 2020, The ocular surface.

[6]  Dong Cheol Lee,et al.  Cyclosporine A eyedrops with self-nanoemulsifying drug delivery systems have improved physicochemical properties and efficacy against dry eye disease in a murine dry eye model , 2019, PloS one.

[7]  M. Pellegrini,et al.  Assessment of Corneal Fluorescein Staining in Different Dry Eye Subtypes Using Digital Image Analysis , 2019, Translational vision science & technology.

[8]  Hyun Seung Kim,et al.  Efficacy of Topical Cyclosporine Nanoemulsion 0.05% Compared with Topical Cyclosporine Emulsion 0.05% and Diquafosol 3% in Dry Eye , 2019, Korean journal of ophthalmology : KJO.

[9]  T. Simpson,et al.  Review and analysis of grading scales for ocular surface staining. , 2019, The ocular surface.

[10]  Raphael Soh Qin,et al.  Healthcare delivery in meibomian gland dysfunction and blepharitis. , 2019, The ocular surface.

[11]  J. Nichols,et al.  Impact of the 2011 International Workshop on Meibomian Gland Dysfunction on clinical trial attributes for meibomian gland dysfunction. , 2019, The ocular surface.

[12]  F. Sezgin,et al.  The Effect of Ocular Demodex Colonization on Schirmer test and OSDI Scores in Newly Diagnosed Dry Eye Patients. , 2019, Eye & contact lens.

[13]  J. Shimazaki.  Definition and Diagnostic Criteria of Dry Eye Disease: Historical Overview and Future Directions. , 2018, Investigative ophthalmology & visual science.

[14]  S. Amano.  Meibomian Gland Dysfunction: Recent Progress Worldwide and in Japan. , 2018, Investigative ophthalmology & visual science.

[15]  Tomo Suzuki.  Inflamed Obstructive Meibomian Gland Dysfunction Causes Ocular Surface Inflammation. , 2018, Investigative ophthalmology & visual science.

[16]  Guei-Sheung Liu,et al.  Ocular Drug Delivery: Role of Degradable Polymeric Nanocarriers for Ophthalmic Application , 2018, International journal of molecular sciences.

[17]  Konstadinos G. Boboridis,et al.  Evaluating the novel application of cyclosporine 0.1% in ocular surface disease , 2018, Expert opinion on pharmacotherapy.

[18]  H. Kim,et al.  Clinical efficacy of combined topical 0.05% cyclosporine A and 0.1% sodium hyaluronate in the dry eyes with meibomian gland dysfunction. , 2018, International journal of ophthalmology.

[19]  C. Baudouin,et al.  Proinflammatory Markers, Chemokines, and Enkephalin in Patients Suffering from Dry Eye Disease , 2018, International journal of molecular sciences.

[20]  Stefano Bonini,et al.  Clinical impact of inflammation in dry eye disease: proceedings of the ODISSEY group meeting , 2017, Acta ophthalmologica.

[21]  G. Sivaramakrishnan,et al.  Therapies for Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials , 2017, The open ophthalmology journal.

[22]  D. Sullivan,et al.  Do Cyclosporine A, an IL-1 Receptor Antagonist, Uridine Triphosphate, Rebamipide, and/or Bimatoprost Regulate Human Meibomian Gland Epithelial Cells? , 2016, Investigative ophthalmology & visual science.

[23]  Hyun Soo Lee,et al.  Chronic Dry Eye Disease is Principally Mediated by Effector Memory Th17 Cells , 2013, Mucosal Immunology.

[24]  F. Vrečer,et al.  Lipid-based systems as a promising approach for enhancing the bioavailability of poorly water-soluble drugs , 2013, Acta pharmaceutica.

[25]  S. Amano,et al.  Topical diquafosol for patients with obstructive meibomian gland dysfunction , 2013, British Journal of Ophthalmology.

[26]  A. Thakur,et al.  Review Article NANOEMULSION IN ENHANCEMENT OF BIOAVAILABILITY OF POORLY SOLUBLE DRUGS: A REVIEW , 2013 .

[27]  S. Pflugfelder,et al.  Topical cyclosporine A therapy for dry eye syndrome , 2012 .

[28]  Jin A. Choi,et al.  Cyclosporine 0.05% Ophthalmic Emulsion for Dry Eye in Korea: A Prospective, Multicenter, Open-Label, Surveillance Study , 2011, Korean journal of ophthalmology : KJO.

[29]  E. Denkbaş,et al.  Development and characterization of Cyclosporine A loaded nanoparticles for ocular drug delivery: Cellular toxicity, uptake, and kinetic studies. , 2011, Journal of controlled release : official journal of the Controlled Release Society.

[30]  K. Tsubota,et al.  The international workshop on meibomian gland dysfunction: executive summary. , 2011, Investigative ophthalmology & visual science.

[31]  Hyun Joo Lee,et al.  Interleukin-17 in Various Ocular Surface Inflammatory Diseases , 2010, Journal of Korean medical science.

[32]  Jong Soo Lee,et al.  Cinical Effect of Restasis® Eye Drops in Mild Dry Eye Syndrome , 2009 .

[33]  William Farley,et al.  Tear cytokine profiles in dysfunctional tear syndrome. , 2009, American journal of ophthalmology.

[34]  Sushma Talegaonkar,et al.  Development and bioavailability assessment of ramipril nanoemulsion formulation. , 2007, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[35]  A. Acheampong,et al.  Ocular Pharmacokinetics and Safety of Ciclosporin, a Novel Topical Treatment for Dry Eye , 2005, Clinical pharmacokinetics.

[36]  A. Bron,et al.  Meibomian gland dysfunction: a clinical scheme for description, diagnosis, classification, and grading. , 2003, The ocular surface.

[37]  A. Graciaa,et al.  Interactions and coalescence of nanodroplets in translucent O/W emulsions , 1999 .