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      Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients

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          Abstract

          Purpose

          We aimed to evaluate the feasibility of using a modified Schirmer test to determine the increase in tear volume after administration of 3% diquafosol ophthalmic solution (diquafosol 3%) in dry eye patients.

          Patients and methods

          A randomized, multicenter, prospective, double-blind clinical study recruited 50 qualified subjects. They received diquafosol 3% in one eye and artificial tears in the other eye. The study protocol comprised a screening and treatment procedure completed within 1 day. The Schirmer test was performed on closed eyes three times a day. The primary efficacy end points were the second Schirmer test scores 10 minutes after the single dose. Secondary end points were the third Schirmer test scores 3 hours and 40 minutes after the single dose and the symptom scores prior to the second and third Schirmer tests.

          Results

          According to the Schirmer test, 10 minutes after administration, diquafosol 3% significantly increased tear volume compared to artificial tears. Diquafosol 3% and artificial tears both showed significant improvements in the symptom scores compared to baseline. However, there was no significant difference in the symptoms score between diquafosol 3% and artificial tears.

          Conclusion

          The modified Schirmer test can detect a minute change in tear volume in dry eye patients. These findings will be useful in the diagnosis of dry eye, assessment of treatment benefits in daily clinical practice, and the development of possible tear-secreting compounds for dry eye.

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          Most cited references23

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          Methodologies to diagnose and monitor dry eye disease: report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007).

          (2007)
          The role of the Diagnostic Methodology Subcommittee of the Dry Eye Workshop was 1) to identify tests used to screen, diagnose and monitor dry eye disease, 2) to establish criteria for test performance, and 3) to consider the utility of tests in a variety of clinical settings. The committee created a database of tests used to diagnose and monitor dry eye, each compiled by an expert in the field (rapporteur) and presented within a standard template. Development of the templates involved an iterative process between the Chairman of the subcommittee, the rapporteurs, and, at times, an additional group of expert reviewers. This process is ongoing. Each rapporteur was instructed on how to the complete a template, using a proforma template and an example of a completed template. Rapporteurs used the literature and other available sources as the basis for constructing their assigned template. The chairman of the subcommittee modifed the template to produce a standardized version and reviewed it with the rapporteur. The completed database will be searchable by an alphabetical list of test names, as well as by functional groupings, for instance, tests of aqueous dynamics, lipid functions, etc. The templates can be accessed on the website of the Tear Film and Ocular Surface Society (www.tearfilm.org). This report provides a general overview of the criteria applied in the development of tests for screening and diagnosis.
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            Dry eye disease treatment: a systematic review of published trials and a critical appraisal of therapeutic strategies.

            Dry eye disease (DED) treatment is an area of increasing complexity, with the emergence of several new treatment agents in recent years. Evaluation of the efficacy of these agents is limited by heterogeneity in outcomes definition and the small number of comparative studies. We provide a systematic review of clinical trials (CTs) related to DED treatment and a critical appraisal of CT public databases. CT reports obtained from eight databases were reviewed, as well as public free-access electronic databases for CT registration. Data evaluation was based on endpoints such as symptoms, Schirmer test, ocular surface staining scores, recruitment of patients, type and efficacy of the drug, and the design and site of performance of the study. Forty-nine CTs were evaluated involving 5,189 patients receiving DED treatment. Heterogeneity in study design prevented meta-analysis from yielding meaningful results, and a descriptive analysis of these studies was conducted. The most frequent categories of drugs for DED in these studies were artificial tears, followed by anti-inflammatory drugs and secretagogues. Although 116 studies have been completed, according to the registration database for clinical trials, only 17 of them (15.5%) were published. Out of 185 registered CTs related to DED, 72% were performed in the USA. The pharmaceutical industry sponsored 78% of them. The identification of effective DED treatment strategies is hindered by the lack of an accepted set of definitive criteria for evaluating disease severity. Copyright © 2013 Elsevier Inc. All rights reserved.
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              Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: a Japanese phase 2 clinical trial.

              To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                1177-5467
                1177-5483
                2016
                13 May 2016
                : 10
                : 879-886
                Affiliations
                [1 ]Ophthalmic Disease Area Strategy Department, R&D Division, Santen Pharmaceutical Co., Ltd. Osaka, Japan
                [2 ]Clinical Operations Department, R&D Division, Santen Pharmaceutical Co., Ltd. Osaka, Japan
                [3 ]Data Science Department, R&D Division, Santen Pharmaceutical Co., Ltd. Osaka, Japan
                Author notes
                Correspondence: Hideki Miyake, Ophthalmic Disease Area Strategy Department, R&D Division, Santen Pharmaceutical Co., Ltd., 4-20 Ofuka-cho, Kita-ku, Osaka 530-8552, Japan, Tel +81 6 4802 9384, Fax +81 6 6359 3846, Email hideki.miyake@ 123456santen.co.jp
                Article
                opth-10-879
                10.2147/OPTH.S105275
                4874632
                27257372
                c28e87d4-94b4-4162-af96-54cbf9339be5
                © 2016 Miyake et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Ophthalmology & Optometry
                p2y2,efficacy,diquas®
                Ophthalmology & Optometry
                p2y2, efficacy, diquas®

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