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.

scholarly journals Dry eye disease among Glaucoma patients on topical hypotensive medications, in a tertiary hospital, Ethiopia

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Miraf Sahlu ◽  
Abeba T. Giorgis
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Signs And Symptoms ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Eye Drops ◽  
Schirmer Test ◽  
Ocular Surface Disease Index ◽  
Cross Sectional ◽  
Corneal Staining

Abstract Background Dry eye disease is a multifactorial disease; causing various ocular symptoms with potential damage to the ocular surface. Applying hypotensive eye drops are presumed to initiate or exacerbate existing dry eye disease. The purpose of this study was to determine the frequency of signs and symptoms and severity of dry eye disease among glaucoma patients on topical hypotensive medications and controls. Methods A cross-sectional comparative study, involving 320 glaucoma patients and controls. Ocular Surface Disease Index (OSDI) symptoms score and Schirmer, tear breakup time and corneal staining tests were used to assess dry eye disease. Data was analyzed using SPSS version 24 software; p-value less than 0.05 was considered as statistically significant. Results Among the 160 study glaucoma patients, the mean duration of topical hypotensive medication use was 5.2 ± 5.21 years (range, 4 months - 32 years). Mild to severe level of OSDI score was found in 122 (76%) glaucoma patients and in 137 (86%) controls (p = 0.033). Mild to sever abnormal clinical tests in the glaucoma patients and control, respectively, were 106 (66%) vs 80 (50%) corneal staining (p = 0.045), 79 (49%) vs 72 (45%) TBUT (p = 0.021), and 91 (57%) vs 83 (52%) Schirmer test (p = 0.242). Test results at the level of sever: 2 (1%) vs 0 (0%) corneal staining, 50 (31%) vs 39 (24%) TBUT and 65 (41%) vs 60 (38%) Schirmer test in the glaucoma patents and controls, respectively. Corneal staining and TBUT had correlation with the number of drugs (p = 0.004 and 0.031, respectively), and more relationship of the two tests with total number of drops applied per day (p = 0.01 and p <  0.001, respectively). Patients on pilocarpine and timolol had more corneal staining and lower TBUT [(p = 0.011 and p <  0.001) and (p = 0.04 and 0.012), respectively]. Conclusions The study has identified glaucoma patients to be more affected by dry eye disease than non-glaucoma patients, and presence of significantly lower TBUT and higher corneal staining in the glaucoma patients on multidrops and multidose per day. We recommend consideration of evaluation and management of DED for glaucoma patients on multidrops and multidose hypotensive medications.

scholarly journals Comparison of treatment efficacy between 100% platelet-rich plasma and 100% serum eye drops in moderate-to-severe dry eye disease: a randomised controlled trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048479
Author(s):  
Passara Jongkhajornpong ◽  
Pawin Numthavaj ◽  
Thunyarat Anothaisintawee ◽  
Kaevalin Lekhanont ◽  
Gareth McKay ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Dry Eye Disease ◽  
Autologous Serum ◽  
Eye Disease ◽  
Eye Drops ◽  
Department Of Ophthalmology ◽  
Autologous Platelet

IntroductionDry eye disease (DED) is a common eye problem. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden, especially in patients with moderate-to-severe DED. Several biological tear substitutes (eg, autologous serum (AS), autologous platelet-rich plasma (APRP) and autologous platelet lysate) could effectively improve dry eyes. However, evidence on their comparative efficacy is controversial. This study aims to compare the efficacy of 100% APRP with 100% AS eye drops in patients with moderate-to-severe DED.Methods and analysisThe study is a single-centre, double-blinded randomised, parallel, non-inferiority trial. One hundred and thirty patients with moderate-to-severe DED, aged 18–70 years will be recruited from outpatient clinic, Department of Ophthalmology, Ramathibodi Hospital, Bangkok from February 2021 to January 2023. Patients will be randomised to receive either 100% APRP or 100% AS eye drops (1:1 ratio) for 4 weeks. The primary outcomes are ocular surface disease index (OSDI) and ocular surface staining (OSS) evaluated using the Oxford scale. Secondary outcomes are fluorescein break-up time, Schirmer’s I test, meibomian gland parameters and adverse events. Other measured outcomes include best-corrected visual acuity, intraocular pressure and compliance.Ethics and disseminationThe study protocol and any supplements used in conducting this trial have been approved by the Ethics Committee of Faculty of Medicine, Ramathibodi Hospital, Mahidol University (MURA2020/1930). Informed consent will be obtained from all patients before study entry. Results will be presented in peer-reviewed journals and international conferences.Trial registration numberNCT04683796.

scholarly journals The effect of tamarind seed polysaccharidecontaining eye drop in dry eye syndrome: Results of an interventional, comparative, clinical study

2021 ◽  
Vol 2 (2) ◽  
pp. 71-76
Author(s):  
Naser Nozari ◽  
Shahrokh Ramin
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Ocular Surface Disease ◽  
Eye Disease ◽  
Eye Drops ◽  
Artificial Tears ◽  
Mean Values ◽  
The Mean ◽  
Contralateral Eye

Background: The mainstay of dry eye treatment is artificial tear solutions. Contralateral eye comparison of 2 types of artificial tears (Xiloial versus Tearlose) in managing dry eye disease was sought in this study. Methods: This study was a prospective, interventional, contralateral eye comparison of 2 types of artificial tears used for managing dry eye disease. The study participants were categorized into mild (13–22 points), moderate (23–32 points), or severe (33–100 points) ocular surface disease according to the baseline ocular surface disease index (OSDI) questionnaire score. Schirmer I and tear film break-up time (TBUT) tests, as well as detailed slit-lamp examinations, were performed at baseline and at the end of the study. All participants received Xiloial monodose eye drops for the right eye and Tearlose eye drops for the left eye, administered as a single drop 4 times per day. Furthermore, they were instructed to perform lid hygiene every 12 hours per day for both eyes. Results: Thirty-five patients (70 eyes) with a mean ± standard (SD) age of 50.2 ± 13.4 years were included, and 14 (40%) were men. The mean ± SD of the OSDI score was 44.24 ± 22.59 at baseline. Of the 35 patients, 10 (28.6%), 5 (14.3%), and 20 (57.1%) had mild, moderate, and severe ocular surface disease, respectively, according to the baseline OSDI score. Compared to baseline, the mean values of both TBUT and Schirmer I tests improved significantly in both groups (both P < 0.001). In comparing the final mean values between the 2 groups, this improvement was comparable for the Schirmer I test (P = 0.179), but TBUT in Tearlose-instilled eyes improved significantly more than in the fellow eyes (P < 0.001). Conclusions: Both Xiloial and Tearlose eye drops improved tear stability and tear production after a 2 week treatment period in eyes with dry eye disease. This improvement was comparable for tear production, but Tearlose-instilled eyes showed significantly greater improvement in tear stability. Further studies with longer follow-up and larger sample sizes could provide more reliable results as a basis for the clinical use of this TSP-containing lubricant eye drop solution in dry eye disease.

scholarly journals Current treatment modalities for dry eye disease

2021 ◽  
Vol 21 (1) ◽  
pp. 18-23
Author(s):  
E.B. Tatarnikova ◽  
◽  
O.I. Krivosheina ◽  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Tear Film ◽  
Current Treatment ◽  
Dry Eye Disease ◽  
Treatment Modalities ◽  
Eye Disease ◽  
Published Data ◽  
Eye Drops ◽  
Anti Inflammatory

For many years, dry eye disease (DED) is a common ophthalmic condition associated with ocular surface damage and loss of homeostasis of the tear film. The key pathogenic factors of DED are tear film instability and tear hyperosmolarity, ocular surface inflammation and damage, and neurosensory alterations. Current treatment for DED consists of non-medical therapies, tear substitutes, anti-inflammatory agents, and surgical procedures. These treatments improve disease course and quality of life. However, these treatments are largely palliative as long-term (and even life-long) installation of eye drops is required. Modern and effective treatments for DED are needed. This paper reviews domestic and foreign published data on the important therapies for DED and novel tools to promote symptom relief. These data are required for the understanding of the pharmacological effects of various drug classes prescribed for DED and early treatment initiation. Keywords: dry eye disease, tear replacement therapy, anti-inflammatory treatment, surgery, hyaluronic acid, preservatives. For citation: Tatarnikova E.B., Krivosheina O.I. Current treatment modalities for dry eye disease. Russian Journal of Clinical Ophthalmology. 2021;21(1):18–23. DOI: 10.32364/2311-7729-2021-21-1-18-23.

scholarly journals Blood-Based Treatments for Severe Dry Eye Disease: The Need of a Consensus

2019 ◽  
Vol 8 (9) ◽  
pp. 1478 ◽  
Author(s):  
Federico Bernabei ◽  
Matilde Roda ◽  
Marina Buzzi ◽  
Marco Pellegrini ◽  
Giuseppe Giannaccare ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Cellular Proliferation ◽  
Treatment Options ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Extensive Literature ◽  
Eye Drops ◽  
Persistent Epithelial Defect ◽  
Preparation Methods

The use of blood-based eye drops as therapy for various diseases of the ocular surface has become increasingly popular in ophthalmic practice during recent years. The rationale for their use is based on the promotion of cellular proliferation and migration thanks to the supply of metabolically active substances, in particular growth factors. Blood-derived eye drops have been used for the treatment of several ocular surface disorders, such as dry eye disease, corneal ulcer, persistent epithelial defect, neurotrophic keratitis, ocular surface burn, recurrent corneal erosion, and limbal stem-cell deficiency. Both autologous (from patients themselves) and heterologous (from adult donors or from cord blood sampled at birth)-derived products exist, and each source has specific pros and cons. Despite an extensive literature, several issues are still under debate and the aim of this manuscript is to review the indications, preparation methods and storage, characterization of content, rationale for clinical outcomes, patient stratification, length of treatment, and rationale for repeated treatments at disease relapse. A rationale based on a “5 Ws and 2 Hs” protocol is proposed as a way of thinking, with the attempt to clarify Who, Why, When, Where, What, and How to use these treatment options.

scholarly journals Therapeutic Potential of „Derived-Multiple Allogeneic Proteins Paracrine Signaling-D-Mapps” in the Treatment of Dry Eye Disease

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Carl Randall Harrell ◽  
Crissy Fellabaum ◽  
Dragica Miloradovic ◽  
Aleksandar Acovic ◽  
Dragana Miloradovic ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Therapeutic Potential ◽  
Ophthalmic Solution ◽  
Chronic Inflammatory Disease ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Eye Drops ◽  
Paracrine Signaling ◽  
Inflammatory Phenotype

Abstract Dry eye disease (DED) is a chronic inflammatory disease of the lacrimal system and ocular surface. Considering the important role of inflammation in DED development, the main treatment strategy has shifted from hydration and lubrication of dry ocular surface to the immunomodulation and immunoregulationapproach that should address the main pathologic processes responsible for disease progression. Due to their capacity for production of immunosuppressive factors, mesenchymal stem cells (MSCs) and their secretome have been considered as potentially new agents in DED therapy. We recently developed an immunomodulatory ophthalmic solution “derived- Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS)” which activity is relied on immunosuppressive capacity of MSC-derived secretome. d-MAPPS contains MSC-derived exosomes, growth factors and immunosuppressive cytokines that are able to efficiently suppress generation of inflammatory phenotype in T cells and macrophages. Herewith, we demonstrated that d-MAPPS protected human corneal epithelial cells from chemical injury and efficiently alleviated ocular discomfort and pain in 131 DED patients during the 12-month follow-up, indicating d-MAPPS eye drops as potentially new remedy for the treatment of DED patients.

scholarly journals Changing Paradigms of Treating Severe Keratitis in Dry Eye Disease

2015 ◽  
Vol 09 (02) ◽  
pp. 121
Author(s):  
Christophe Baudouin ◽  
◽  
◽  
◽  
◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Phase Iii ◽  
Diagnostic Tools ◽  
Eye Disease ◽  
Tolerability Profile ◽  
Eye Drops ◽  
Vicious Cycle ◽  
Formulation Development

These proceedings are based on a symposium, presented at the European Society of Ophthalmology 2015 Congress in Vienna, Austria on 8 June 2015. The symposium was arranged by Santen to bring together leaders in ophthalmology with the objective of exploring advances in the treatment of severe keratitis in dry eye disease (DED). DED is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear instability with potential damage to the ocular surface. Abnormalities at the ocular surface can affect all tear dynamic components, resulting in a vicious cycle that reinforces/sustains DED. Ciclosporin (CsA) is thought to exert an anti-inflammatory effect on ocular surface cells. This compound should be in the near future one of the principal advances in the treatment of DED for blocking the vicious cycle of the disease. Extensive formulation development work has led to the availability of a well-tolerated, stable cationic nanoemulsion, designated as Novasorb® technology. This technology has been used in the first European approved CsA 1 mg/mL eye drops emulsion (Ikervis®) for the treatment of severe keratitis in adult patients with DED, which has not improved despite treatment with tear substitutes. Clinical trials involving over 900 patients have demonstrated a good safety and tolerability profile and significant clinical efficacy of this formulation with a once-daily dosing regimen. CsA 1 mg/mL eye drops were evaluated in the pivotal phase III SANSIKA study, which confirmed the positive benefit–risk profile of CsA 1 mg/mL eye drops for the treatment of severe keratitis in DED. An assessment of ocular surface health requires: listening to the patient, the use of simple diagnostic tools, an expertise in examination, including use of microscopy, and an up-to-date knowledge of current models of DED.

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 In Vivo and Impression Cytology Study on the Effect of Compatible Solutes Eye Drops on the Ocular Surface Epithelial Cell Quality in Dry Eye Patients

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Manuela Lanzini ◽  
Claudia Curcio ◽  
Rossella Annamaria Colabelli-Gisoldi ◽  
Alessandra Mastropasqua ◽  
Roberta Calienno ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Compatible Solutes ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Eye Drops ◽  
Impression Cytology ◽  
Significant Difference

The aim of this study is to investigate in vivo and ex vivo ocular surface alterations induced by dry eye disease and modification after osmoprotective therapy. Forty-eight eyes of 24 patients suffering from dry eye have been recruited. All patients received Optive (compatible solutes) eye drops in one randomly selected eye and Hylogel (sodium hyaluronate 0,2%) in the other. Follow-up included a baseline visit and further examination 30-, 60-, and 90-day intervals (which comprises clinical evaluation, in vivo confocal microscopy—IVCM—of the ocular surface, and conjunctival impression cytology). No significant difference in Schirmer I Test, TBUT, and vital staining results was observed during the follow-up period in both groups. IVCM showed in all patients an improvement of ocular surface epithelial morphology and signs of inflammation (oedema and keratocyte activation). However, these modifications were more evident in patients treated with Optive therapy. A significant reduction of the expression of MMP9 and IL6 in Optive group was observed during the follow-up period in comparison to Hylogel treatment. Our results show that in dry eye disease therapy based on osmoprotective eye drops determines a reduction of inflammatory activation of ocular surface, with consequent improvement of the quality of corneal and conjunctival epithelium.

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