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      The effectiveness of olopatadine hydrochloride eye drops for allergic conjunctivitis : Protocol for a systematic review

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          Abstract

          Background:

          Allergic conjunctivitis (AC) is a multifactorial and common type of ocular surface disease that affects many people. The quality of life for AC patients can be significantly decreased caused by symptoms of ocular itching, swelling, redness, and tearing. Topical antihistaminics, mast cell stabilizers, non-steroidal anti-inflammatory drugs (NSAIDs), and steroids have been widely used to treat AC. Many clinical trials have indicated that olopatadine hydrochloride eye drops can provide quick relief of symptoms and signs. The purpose of this review is to evaluate systematically the effectiveness of olopatadine hydrochloride eye drops for treating AC.

          Methods:

          A systematic review of all of the randomized controlled trials on the effectiveness and safety of olopatadine hydrochloride eye drops for AC will be conducted. We will search PubMed, Web of Science (WOS), EMBASE (OVID), the Cochrane Library, Google Scholar, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal database (VIP), Wanfang Database, and CBM, from the database inception date to October 31, 2019. There are no language or publication status restrictions. Registers of clinical trials, potential gray literature, reference lists of studies, and conference abstracts will also be searched. Two reviewers will independently read the articles, extract the data information, and assess the quality of the studies. Data will be synthesized by a heterogeneity test. The primary outcomes include the main symptom and sign scores before and after treatment, the eye redness index, the presence of eosinophils in the conjunctival scraping. Quality of life, the total treatment efficacy, and safety will be evaluated as the secondary outcomes. RevMan V.5.3 software will be used for the meta-analysis.

          Results:

          The study will provide an objective and normative systematic review to evaluate the effectiveness and safety of olopatadine hydrochloride eye drops for the treatment of AC.

          Conclusion:

          Our review will provide useful information to judge whether olopatadine hydrochloride eye drops is an effective intervention for patients with AC.

          Ethics and dissemination:

          It is not necessary to obtain ethical approval as participants are not involved patients. The protocol and results will be published in a peer-reviewed journal. The systematic review will also be disseminated electronically and in print to help guide health care practice and policy.

          Prospero registration number:

          PROSPERO CRD42019132232.

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          Most cited references22

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          Evaluation of the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation

          Background In 2008, the Cochrane Collaboration introduced a tool for assessing the risk of bias in clinical trials included in Cochrane reviews. The risk of bias (RoB) tool is based on narrative descriptions of evidence-based methodological features known to increase the risk of bias in trials. Methods To assess the usability of this tool, we conducted an evaluation by means of focus groups, online surveys and a face-to-face meeting. We obtained feedback from a range of stakeholders within The Cochrane Collaboration regarding their experiences with, and perceptions of, the RoB tool and associated guidance materials. We then assessed this feedback in a face-to-face meeting of experts and stakeholders and made recommendations for improvements and further developments of the RoB tool. Results The survey attracted 380 responses. Respondents reported taking an average of between 10 and 60 minutes per study to complete their RoB assessments, which 83% deemed acceptable. Most respondents (87% of authors and 95% of editorial staff) thought RoB assessments were an improvement over past approaches to trial quality assessment. Most authors liked the standardized approach (81%) and the ability to provide quotes to support judgements (74%). A third of participants disliked the increased workload and found the wording describing RoB judgements confusing. The RoB domains reported to be the most difficult to assess were incomplete outcome data and selective reporting of outcomes. Authors expressed the need for more guidance on how to incorporate RoB assessments into meta-analyses and review conclusions. Based on this evaluation, recommendations were made for improvements to the RoB tool and the associated guidance. The implementation of these recommendations is currently underway. Conclusions Overall, respondents identified positive experiences and perceptions of the RoB tool. Revisions of the tool and associated guidance made in response to this evaluation, and improved provision of training, may improve implementation.
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            Quantifying heterogeneity in individual participant data meta-analysis with binary outcomes

            Background In meta-analyses (MA), effect estimates that are pooled together will often be heterogeneous. Determining how substantial heterogeneity is is an important aspect of MA. Method We consider how best to quantify heterogeneity in the context of individual participant data meta-analysis (IPD-MA) of binary data. Both two- and one-stage approaches are evaluated via simulation study. We consider conventional I 2 and R 2 statistics estimated via a two-stage approach and R 2 estimated via a one-stage approach. We propose a simulation-based intraclass correlation coefficient (ICC) adapted from Goldstein et al. to estimate the I 2, from the one-stage approach. Results Results show that when there is no effect modification, the estimated I 2 from the two-stage model is underestimated, while in the one-stage model, it is overestimated. In the presence of effect modification, the estimated I 2 from the one-stage model has better performance than that from the two-stage model when the prevalence of the outcome is high. The I 2 from the two-stage model is less sensitive to the strength of effect modification when the number of studies is large and prevalence is low. Conclusions The simulation-based I 2 based on a one-stage approach has better performance than the conventional I 2 based on a two-stage approach when there is strong effect modification with high prevalence. Electronic supplementary material The online version of this article (doi:10.1186/s13643-017-0630-4) contains supplementary material, which is available to authorized users.
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              Management of seasonal allergic conjunctivitis: guide to therapy.

              Seasonal allergic conjunctivitis (SAC) is an inflammatory response of the conjunctiva triggered by exposure to seasonal allergens. Treatment options for SAC include artificial tears, antihistamines, decongestants, mast cell stabilizers, nonsteroidal anti-inflammatory drugs, dual antihistamine/mast cell stabilizers, immunotherapy and corticosteroids. Topical, intranasal and systemic formulations of corticosteroids have traditionally provided the most effective relief of the inflammation and signs and symptoms associated with severe, acute exacerbations of SAC. However, steroid-induced ocular and systemic side-effects have limited the prescribing of these agents. This limitation of traditional corticosteroids led to the development of modified corticosteroids that retain the anti-inflammatory mechanism of action of traditional corticosteroids with a much-improved safety profile because of their rapid breakdown to inactive metabolites after exerting their activity. The development of one such novel corticosteroid, loteprednol etabonate (LE), led to the insertion of an ester (instead of a ketone) group at the carbon-20 (C-20) position of the basic corticosteroid structure. Clinical trials assessing this C-20 ester corticosteroid have demonstrated similar efficacy to C-20 ketone corticosteroids in the prevention or treatment of the signs and symptoms of SAC but with a greatly improved safety profile, as the C-20 ester corticosteroid is less likely to elevate intraocular pressure. In addition, the ketone at the C-20 position has been implicated in the formation of cataract, while nonketolic corticosteroids do not form Schiff base intermediates with lens proteins, which is a common first step in cataractogenesis. The clinical relevance of the C-20 ester corticosteroid class, as modelled by LE, is that they provide both effective and safe treatment of the inflammation associated with SAC and relief of its signs and symptoms. Loteprednol etabonate offers a well-tolerated treatment option for patients with debilitating acute exacerbations as well as chronic forms of the disease. © 2011 The Authors. Acta Ophthalmologica © 2011 Acta Ophthalmologica Scandinavica Foundation.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                February 2020
                14 February 2020
                : 99
                : 7
                : e18618
                Affiliations
                [a ]Beijing University of Chinese Medicine
                [b ]Department of Ophthalmology, China-Japan Friendship Hospital, Beijing, China.
                Author notes
                []Correspondence: Ming Jin, Department of Ophthalmology, China-Japan, Friendship Hospital, No. 2, Yinghua Donglu, Chaoyang District, Beijing 100029, China (e-mail: jinmingyk@ 123456163.com ).
                Article
                MD-D-19-09241 18618
                10.1097/MD.0000000000018618
                7035116
                32049778
                0bd06ab2-c537-407b-b7fb-2ae1a247c8df
                Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 3 December 2019
                : 6 December 2019
                Categories
                5800
                Research Article
                Study Protocol Systematic Review
                Custom metadata
                TRUE

                allergic conjunctivitis,olopatadine hydrochloride eye drops,protocol,systematic review

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