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      Safety and Tolerability of an Eye Drop Based on 0.6% Povidone–Iodine Nanoemulsion in Dry Eye Patients

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          Abstract

          Purpose: To evaluate safety and tolerability on the ocular surface of an anti-septic formulation containing 0.6% povidone–iodine (0.6% PVI) for a 4 week period.

          Methods: An observational, prospective study included 20 mild-moderate dry eye disease (DED) patients who enrolled at the Ocular Surface Disease Unit of the University of Messina, receiving 0.6% PVI eye drops for 28 days, 2 drops twice daily (BID). The assessment included the Ocular Surface Disease Index questionnaire; symptoms score (0 = absent to 3 = severe) for burning, ocular dryness, foreign body sensation, watery eyes, tearing, photophobia, and ocular pain; fluorescein tear break-up time (TBUT); and corneal-conjunctival staining, performed at baseline (T0), after 7 (T7) and 28 (T28). Schirmer I-test, corneal endothelial cell count, intraocular pressure, and fundus examination were performed at T0 and T28. The main outcome measures were TBUT and corneal-conjunctival staining as markers of ocular surface homeostasis. For statistical analysis, Student's T-test and Wilcoxon test were used as appropriate.

          Results: No significant alterations of the safety parameters were found throughout the study. Further, at T28 a significant improvement of burning, ocular dryness, foreign body sensation, and watery eyes (T0 vs. T28 P < 0.03) were observed; corneal-conjunctival staining improved at T28 (T0 vs. T28 P < 0.0001), and TBUT improved already at T7 (T0 vs. T7 P = 0.0008) lasting so till the end of the study. The only adverse event was mild burning at instillation for the first 3 days of treatment in most of the patients.

          Conclusions: The treatment with 0.6% PVI was safe and well tolerated in a group of patients with a damaged ocular surface.

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          Most cited references67

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          Role of the microbiota in immunity and inflammation.

          The microbiota plays a fundamental role on the induction, training, and function of the host immune system. In return, the immune system has largely evolved as a means to maintain the symbiotic relationship of the host with these highly diverse and evolving microbes. When operating optimally, this immune system-microbiota alliance allows the induction of protective responses to pathogens and the maintenance of regulatory pathways involved in the maintenance of tolerance to innocuous antigens. However, in high-income countries, overuse of antibiotics, changes in diet, and elimination of constitutive partners, such as nematodes, may have selected for a microbiota that lack the resilience and diversity required to establish balanced immune responses. This phenomenon is proposed to account for some of the dramatic rise in autoimmune and inflammatory disorders in parts of the world where our symbiotic relationship with the microbiota has been the most affected. Copyright © 2014 Elsevier Inc. All rights reserved.
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            TFOS DEWS II Definition and Classification Report

            The goals of the TFOS DEWS II Definition and Classification Subcommittee were to create an evidence-based definition and a contemporary classification system for dry eye disease (DED). The new definition recognizes the multifactorial nature of dry eye as a disease where loss of homeostasis of the tear film is the central pathophysiological concept. Ocular symptoms, as a broader term that encompasses reports of discomfort or visual disturbance, feature in the definition and the key etiologies of tear film instability, hyperosmolarity, and ocular surface inflammation and damage were determined to be important for inclusion in the definition. In the light of new data, neurosensory abnormalities were also included in the definition for the first time. In the classification of DED, recent evidence supports a scheme based on the pathophysiology where aqueous deficient and evaporative dry eye exist as a continuum, such that elements of each are considered in diagnosis and management. Central to the scheme is a positive diagnosis of DED with signs and symptoms, and this is directed towards management to restore homeostasis. The scheme also allows consideration of various related manifestations, such as non-obvious disease involving ocular surface signs without related symptoms, including neurotrophic conditions where dysfunctional sensation exists, and cases where symptoms exist without demonstrable ocular surface signs, including neuropathic pain. This approach is not intended to override clinical assessment and judgment but should prove helpful in guiding clinical management and research.
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              TFOS DEWS II Diagnostic Methodology report

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                Author and article information

                Journal
                J Ocul Pharmacol Ther
                J Ocul Pharmacol Ther
                jop
                Journal of Ocular Pharmacology and Therapeutics
                Mary Ann Liebert, Inc., publishers (140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA )
                1080-7683
                1557-7732
                March 2021
                04 March 2021
                04 March 2021
                : 37
                : 2
                : 90-96
                Affiliations
                [ 1 ]Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy.
                [ 2 ]Department of Ophthalmology, Vita-Salute University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
                Author notes
                [*]Address correspondence to: Dr. Giovanni William Oliverio, Department of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Via Consolare Valeria, 1, Messina 98125, Italy giovannioliverio89@ 123456gmail.com
                Article
                10.1089/jop.2020.0085
                10.1089/jop.2020.0085
                7984652
                33370213
                37092dc4-7fd9-4ac9-81fe-e3c1aab04b28
                © Giovanni William Oliverio et al. 2021; Published by Mary Ann Liebert, Inc.

                This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : Received: July 30, 2020
                : Accepted: November 11, 2020
                Page count
                Figures: 1, Tables: 2, References: 67, Pages: 7
                Categories
                Original Articles

                povidone–iodine,dry eye disease,microbiota,antiseptic,antibiotic resistance,ocular surface

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