Is there a role for tapered topical dose steroidal treatment for dry eye disease? A randomized, pilot study

2021 ◽  
pp. 112067212110487
Author(s):  
Stefano Barabino ◽  
Elisa Montaldo ◽  
Maria Cristina Mingari ◽  
Cosimo Mazzotta ◽  
Sebastiano Giuffrida ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Loteprednol Etabonate ◽  
Hla Dr ◽  
Eye Symptoms ◽  
Conjunctival Cells ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

Purpose: To evaluate the effect of tapered doses of loteprednol-etabonate in dry eye disease patients. Materials and methods: Dry eye and treatment outcomes were assessed by Schirmer I test, tear BUT, lissamine green conjunctival staining, fluorescein corneal staining, and HLA-DR expression on conjunctival cells. Patients received either loteprednol-etabonate 0.5% twice daily for 14 days tapered to once daily for 14 days, and then twice weekly for 28 days ( n = 10), or NaCl 0.9%. Results: A significant decrease of ocular surface inflammation and improvement of symptoms was recorded in the study group compared with controls at days 14 and 56. Change from baseline in HLA-DR expression in CD45+ conjunctival cells was significantly higher in treated patients at day 14. Intraocular pressure and best corrected visual acuity were preserved in all treated eyes. Conclusions: Tapered doses of loteprednol etabonate 0.5% suspension controlled ocular surface inflammation, improving dry eye symptoms.

scholarly journals One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease

2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

Purpose The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE). Methods In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups). Results A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA. Conclusions In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.

scholarly journals The Protective Effect of Polyunsaturated Fatty Acids against Dry Eye Disease: A Literature Review

2021 ◽  
Vol 11 (10) ◽  
pp. 4519
Author(s):  
Joon-Young Hyon ◽  
Sang-Beom Han
Keyword(s):  
Fatty Acids ◽  
Polyunsaturated Fatty Acids ◽  
Dry Eye ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Common Disease ◽  
Anti Inflammatory ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

Dry eye disease (DED) is a common disease, and have an adverse effect the physical, functional, and psychological quality of life. It is a multifactorial disorder characterized by the loss of tear film homeostasis, in which self-perpetuating vicious cycle leads to deterioration of function and inflammation of the lacrimal functional unit. Hence, treatment strategies should be aimed at the interruption of the vicious inflammatory cycle and alleviation of ocular surface inflammation. Anti-inflammatory therapies have been shown to improve the signs and symptoms of the disease. Evidence indicates that polyunsaturated fatty acids (PUFAs) may contribute to reinforcement of innate anti-inflammatory mechanisms, and systemic and topical administration of PUFAs may help modulate ocular surface inflammation. In the present review, the authors will introduce the results of clinical and experimental studies to elucidate the mechanism, efficacy, and safety of systemic and topical supplementation with PUFAs as an alternative therapeutic strategy for DED. This review will also include discussion regarding current perspectives, including evidence-based recommendations and possible side effects of PUFAs supplementation. The review of the literature suggests that PUFAs supplementation can be a viable option for the treatment of DED, although further studies are needed for establishment of treatment guidelines.

scholarly journals The closed eye harbors a unique microbiome in dry eye disease

2020 ◽  
Author(s):  
Kent A. Willis ◽  
Cameron K. Postnikoff ◽  
Amelia B. Freeman ◽  
Gabriel Rezonzew ◽  
Kelly K. Nichols ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Experimental Models ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Disease Development ◽  
T Helper ◽  
Serial Samples ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

Dry eye affects millions of individuals. In experimental models, dry eye disease is associated with T helper cell 17-mediated inflammation of the ocular surface that may cause persistent damage to the corneal epithelium. However, the initiating and perpetuating factors associated with chronic inflammation of the ocular surface remain unclear. The ocular microbiota alters ocular surface inflammation and may influence dry eye disease development and progression. Here, we collected serial samples of closed eye tears during a randomized clinical trial of a non-pharmaceutical dry eye therapy and used 16S rRNA metabarcoding to characterize the microbiome. We show the closed dry eye microbiome is distinct from the healthy closed eye microbiome. The ocular microbiome was described only recently, and this report implicates a distinct microbiome in ocular disease development. Our findings suggest an interplay between microbial commensals and inflammation on the ocular surface. This information may inform future studies of the pathophysiological mechanisms of dry eye disease.

Corneal lymphangiogenesis facilitates ocular surface inflammation and cell trafficking in dry eye disease

2018 ◽  
Vol 16 (3) ◽  
pp. 306-313 ◽  
Author(s):  
Yong Woo Ji ◽  
Jae Lim Lee ◽  
Hyun Goo Kang ◽  
Nayeong Gu ◽  
Haewon Byun ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Cell Trafficking ◽  
Corneal Lymphangiogenesis ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

scholarly journals The role of KPI-121 0.25% in the treatment of dry eye disease: penetrating the mucus barrier to treat periodic flares

2021 ◽  
Vol 13 ◽  
pp. 251584142110127
Author(s):  
Preeya K. Gupta ◽  
Nandini Venkateswaran
Keyword(s):  
Drug Delivery ◽  
Dry Eye ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Eye Drops ◽  
Short Term ◽  
Short Term Treatment ◽  
Loteprednol Etabonate ◽  
Mucus Barrier

The tear film, which includes mucins that adhere to foreign particles, rapidly clears allergens and pathogens from the ocular surface, protecting the underlying tissues. However, the tear film’s ability to efficiently remove foreign particles during blinking can also pose challenges for topical drug delivery, as traditional eye drops (solutions and suspensions) are cleared from the ocular surface before the drug can penetrate into the conjunctival and corneal epithelium. In the past 15 years, there has been an increase in the development of nanoparticles with specialized coatings that have reduced affinity to mucins and are small enough in size to pass through the mucus barrier. These mucus-penetrating particles (MPPs) have been shown to efficiently penetrate the mucus barrier and reach the ocular surface tissues. Dry eye disease (DED) is a common inflammatory ocular surface disorder that often presents with periodic flares (exacerbations). However, currently approved immunomodulatory treatments for DED are intended for long-term use. Thus, there is a need for effective short-term treatments that can address intermittent flares of DED. Loteprednol etabonate, an ocular corticosteroid, was engineered to break down rapidly after administration to the ocular surface tissues and thereby reduce risks associated with other topical steroids. KPI-121 is an ophthalmic suspension that uses the MPP technology to deliver loteprednol etabonate more efficiently to the ocular tissues, achieving in animal models a 3.6-fold greater penetration of loteprednol etabonate to the cornea than traditional loteprednol etabonate ophthalmic suspensions. In clinical trials, short-term treatment with KPI-121 0.25% significantly reduced signs and symptoms of DED compared with its vehicle (placebo). Recently approved KPI-121 0.25%, with its novel drug delivery design and ease of use, has the potential to effectively treat periodic flares of DED experienced by many patients.

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