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April 2007 Ocular Surface Volume 5, Number 2 THE A JOURNAL OF REVIEW LINKING LABORATORY SCIENCE, CLINICAL SCIENCE, AND CLINICAL PRACTICE A peer-reviewed journal, indexed in MEDLINE/PubMed and EMBASE SPECIAL ISSUE 2007 Report of the International Dry Eye WorkShop (DEWS) Sponsored by the Tear Film & Ocular Surface Society INTRODUCTION TO THE 2007 REPORT OF THE INTERNATIONAL DRY EYE WORKSHOP (DEWS) THE DEFINITION AND CLASSIFICATION OF DRY EYE DISEASE THE EPIDEMIOLOGY OF DRY EYE DISEASE METHODOLOGIES TO DIAGNOSE AND MONITOR DRY EYE DISEASE DESIGN AND CONDUCT OF CLINICAL TRIALS MANAGEMENT AND THERAPY OF DRY EYE DISEASE RESEARCH IN DRY EYE THE OCULAR SURFACE / JANUARY 2003, VOL. 1, NO. 1 1 Ocular THE Surface A JOURNAL OF REVIEW LINKING LABORATORY SCIENCE, CLINICAL SCIENCE, AND CLINICAL PRACTICE A peer-reviewed journal Editors editor-in-chief Gary N. Foulks, MD, FACS Professor, Ophthalmology, University of Louisville, Louisville, KY founding editor Michael A. Lemp, MD Washington, DC section editors laboratory science James V. Jester, PhD Professor, Ophthalmology, University of California, Irvine, CA clinical science, innovative techniques and technology Gary N. Foulks, MD clinical practice John Sutphin, Jr, MD Professor and Chair, Ophthalmology, University of Kansas Medical Center, Kansas City, KS features editors Juan Murube, MD, PhD Professor, Ophthalmology, University of Alcala, Madrid, Spain Gary D. Novack, PhD President, PharmaLogic Development Inc., San Rafael, CA managing editor Susan Erickson Brookline, MA Editorial Board Additional biographical information is available at Mark B. Abelson, MD, Director, Ophthalmic Research Associates, North Andover, MA Penny A. Asbell, MD, Professor, Ophthalmology, Mount Sinai Medical Center, New York, NY Christophe Baudouin, MD, PhD, Professor and Director, Ophthalmology, Quinze-Vingts Hôpital, University of Paris, Paris, France Roger W. Beuerman, PhD, Professor, Ophthalmology, Cell Biology, and Anatomy, Louisiana State University Eye Center, New Orleans, LA, and Singapore Eye Research Institute, Singapore Stefano Bonini, MD, Professor and Chairman, Ophthalmology, University of Rome, Rome, Italy Anthony Bron, FRCS, Professor Emeritus, Nuffield Laboratory of Ophthalmology, Oxford, UK M. Reza Dana, MD, MPH, Senior Scientist, Schepens Eye Research Institute, Boston, MA Darlene A. Dartt, PhD, Senior Scientist, Schepens Eye Research Institute, Boston, MA Harminder S. Dua, MD, PhD, Professor, Ophthalmology and Vision Science, University of Nottingham, UK Suzanne M. J. Fleiszig, OD, PhD, Associate Professor, Vision Science and Optometry, University of California Berkeley, Berkeley, CA Desmond Fonn, Dip Optom, M Optom (NSW), FAAO, Professor, School of Optometry, University of Waterloo, Waterloo, Ontario, Canada Ilene K. Gipson, PhD, Senior Scientist, Schepens Eye Research Institute, Boston, MA W. Bruce Jackson, MD, Professor and Chairman, Ophthalmology, University of Ottawa, Ottawa, Ontario, Canada Winston W.-Y. Kao, PhD, Director, Ophthalmic Research, University of Cincinnati, Cincinnati, OH Shigeru Kinoshita, MD, Professor and Chairman, Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan Friedrich E. Kruse, MD, Professor and Chairman, University Eye Clinic, University of Erlangen-Nuremberg, Erlangen, Germany Peter Laibson, MD, Co-director, Cornea Service, Wills Eye Hospital, Philadelphia, PA Mark J. Mannis, MD, Professor, Ophthalmology, University of California, Davis, Davis, CA William D. Mathers, MD, Professor, Casey Eye Institute, Oregon Health Sciences University, Portland, OR James P. McCulley, MD, Professor and Chairman, Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX Austin K. Mircheff, PhD, Professor, Physiology and Biophysics, and Ophthalmology, Doheny Eye Institute, University of Southern California, Los Angeles, CA Teruo Nishida, MD, Professor and Chairman, Biomolecular Recognition and Ophthalmology, Yamaguchi University School of Medicine, Yamaguchi, Japan Stephen C. Pflugfelder, MD, Professor, Ophthalmology, Baylor College of Medicine, Houston, TX Kenneth A. Polse, OD, MS, Professor, Vision Science and Optometry, University of California, Berkeley, Berkeley, CA Gullapalli N. Rao, MD, Director, LV Prasad Eye Institute, Hyderabad, India Maurizio Rolando, MD, Professor, Neuroscience and Ophthalmology, University of Genoa, Genoa, Italy Janine Smith, MD, Deputy Clinical Director, National Eye Institute, National Institutes of Health, Bethesda, MD Michael E. Stern, PhD, Research Investigator, Allergan Inc., Irvine, CA David A. Sullivan, PhD, Senior Scientist, Schepens Eye Research Institute, Boston, MA Deborah F. Sweeney, OD, PhD, Associate Professor, University of New South Wales, Sydney, NSW, Australia Donald T. Tan, FRCS, Director, Singapore Eye Research Institute, National University of Singapore, Singapore Timo Tervo, MD, PhD, Professor, Applied Clinical Ophthalmology, Helsinki University Eye Hospital, Helsinki, Finland Alan Tomlinson, PhD, DSc, FCOptom, Professor and Head, Vision Sciences, Glasgow Caledonian University, Glasgow, Scotland, UK Scheffer Tseng, MD, PhD, President, Ocular Surface Center, Miami, FL Kazuo Tsubota, MD, Professor and Head, Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan Graeme Wilson, PhD, Professor, Optometry, Indiana University, Bloomington, IN 60 The Ocular Surface / April 2007, Vol. 5, No. 2 / 60 Ocular THE Surface A JOURNAL OF REVIEW LINKING LABORATORY SCIENCE, CLINICAL SCIENCE, AND CLINICAL PRACTICE A peer-reviewed journal Article submission: Questions regarding manuscript preparation not addressed in the Information for Authors may be addressed to the Managing Editor: Susan Erickson, 130 Winchester St., Brookline, MA Tel: ; Information for Authors is available at Subscription rates Individual: $154 per year in the US and Canada; $199 per year rest of world (includes air mail delivery). Institution:$249 per year in the US and Canada; $299 per year rest of world (includes air mail delivery). Internetonly subscription: $139 (US and rest of world). Print-only subscription: $139 (US and Canada); $139 (rest of world). Back issues are $45 per issue. Subscriptions may be ordered online at or at The Ocular Surface, 75 Maiden Lane, Suite 408, New York, NY 10038, USA. tel: fax: Claims for missing issues must be filed within 120 days of the issue date. Indexing The Ocular Surface is indexed in MEDLINE/ PubMed and EMBASE. The Ocular Surface is printed on acid-free paper that meets the requirements of ANSI/NISO Z (Permanence of Paper). Library reprints Contact the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA USA. tel: ; fax: com online: Advertising and bulk reprint inquiries should be addressed to LaVon Kellner, Ethis Communications, Inc., 75 Maiden Lane, Suite 408, New York, NY tel: ; fax: ; Contact authors for single reprint copies. The Ocular Surface (ISSN ) is published quarterly by Ethis Communications, Inc., 75 Maiden Lane, Suite 408, New York, NY 10038, USA. Copyright 2006 Ethis Communications, Inc. All rights reserved. Neither The Ocular Surface nor the publisher assume any responsibility for any injury and/or damage to persons or property as a matter of product liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in this publication. No part of these contents may be reproduced without permission. publisher, director of global sales: LaVon Marie Kellner editorial director: David Kellner art director: DeborahAnne Chingas Sandke production director: Charlotte L. Latham circulation manager: Simon Wang The Ocular Surface / April 2007, Vol. 5, No. 2 / 59 Editorial DEWS Report: A Mission Completed T his issue of The Ocular Surface is very unusual. As the official report of the Dry Eye Work- Shop (DEWS), it is an encyclopedic review of dry eye disease and, additionally, a guide to resources archived on the internet. It is the product of a team of international experts who have labored over 3 years to compile an evidence-based review of the present state of knowledge for dry eye disease and the methods used to evaluate, diagnose, and manage the disorder. It summarizes the findings of current research and identifies future needs for a better understanding of the etiology, pathogenesis, and potential therapy of the disease. The process of deliberation and discussion that underpins this arduous endeavor is described in the Introduction and in various chapters of the volume. Suffice it to say that an international community of clinicians and scientists with expertise in all aspects of dry eye disease collaborated to search the literature, collect and validate data, and incorporate it into reports. The process of commentary and adjudication of differing opinions was open, yet subject to several levels of validation. The product is a written document that serves as a guide to a vast amount of information that is archived both in this special issue and on a supporting website (www.tearfilm.org) that is accessible to all. The chapter on Definition and Classification expands the characterization of dry eye disease and places it within the perspective of ocular surface disease. The chapter on Epidemiology provides commentary on the implications of the disease, as well as comparison of the methods available to evaluate symptoms and factors contributory to the disease. The Diagnostic Methodologies chapter not only provides valuable discussion of the parameters of dry eye disease, but also catalogs and validates a vast collection of clinical and research methods, including questionnaires, to monitor the disease. The Research chapter summarizes past and present findings, and identifies areas whose further study will contribute to the understanding of the etiopathogenesis and consequences of dry eye disease. The chapter on Clinical Trials provides recommendations with regard to both general and specific guidelines for clinical trials in dry eye disease and identifies the idiosyncrasies and confounding outcome variables for such trials. The chapter on Management and Therapy catalogs the options for therapy and recommends a contemporary strategy for management of dry eye disease. As would be expected for a multifactorial disease that has many nuances in clinical and pathological expression, opinions differ even amongst the experts as to the most appropriate way to characterize and label some aspects of the disease. This proved true for the definition and classification of the disease. Some key concepts in the appreciation of dry eye were identified from the literature. One such concept was the characterization of the Lacrimal Functional Unit, 1 which has highlighted the interdependence of components of the lacrimal system in maintaining the integrity of the ocular surface. Some new concepts were constructed in the deliberation process of the Subcommittee work, including a concept suggested by Dr. Christophe Baudoin a Vicious Circle of dry eye disease, by which various risk factors may interact to precipitate and perpetuate the condition. 2 The concept of the Ocular Surface System, developed by the Research Subcommittee, extends the scope of the ocular surface to a collection of contiguous tissues that share embryonal, innervational, histological, and hormonal background. The time and effort necessary to compile and collate this project and the summary document was extraordinary. The endeavor could never have been completed without the sponsorship and commitment of The Tear Film & Ocular Surface Society and the officers and staff of that organization. The planning and execution of the organizational meetings, the coordination of the conferences for presentation of the collected information, the facilitation of the discussions of the DEWS participants, and the administrative direction of the publication process were achieved through the tireless efforts of Dr. David A., Rose M. and Amy G. Sullivan. The deliberations of the Steering Committee were essential to the completion of the task. Likewise, the leaders of the various Subcommittees were in- The Ocular Surface / April 2007, Vol. 5, No. 2 / Editorial continued strumental in providing the building blocks for construction of the final product. A special congratulations and thank you is due Professor Anthony J. Bron, who devoted endless hours and energy to leading the writing team through multiple iterations of the text and the references to provide a harmonization of the various reports. The ultimate coordination and editing of the document was in the capable hands of Susan Erickson, for whom we are most appreciative. Particular appreciation is extended to Ethis Communications, Inc. for embracing the publication of this work, which should serve as a valuable reference for all those who investigate and manage patients with dry eye disease. Last but far from least is a heartfelt thank you to the Corporate Sponsors of the Dry Eye WorkShop, who provided the financial resources and encouragement to complete this project. I wish you good reading and great referencing. Gary N. Foulks, MD, FACS Editor-in-Chief references 1. Stern ME, Gao J, Siemasko KF, et al. The role of the lacrimal functional unit in the pathophysiology of dry eye. Exp Eye Res 2004;78(3): Baudoin C. [The vicious circle in dry eye syndrome: a mechanistic approach] J Fr Ophtalmol 2007;30: The Ocular Surface / April 2007, Vol. 5, No. 2 / Table of Contents April 2007, Volume 5, Number 2 Special Issue 2007 Report of the International Dry Eye WorkShop (DEWS) Sponsored by the Tear Film & Ocular Surface Society 69 Introduction to the 2007 Report of the International Dry Eye WorkShop (DEWS) 71 Membership of the International Dry Eye WorkShop (DEWS) 73 Glossary 75 The Definition and Classification of Dry Eye Disease 93 The Epidemiology of Dry Eye Disease 108 Methodologies to Diagnose and Monitor Dry Eye Disease 153 Design and Conduct of Clinical Trials 163 Management and Therapy of Dry Eye Disease 179 Research in Dry Eye 195 Index 202 Disclosure of Financial/Proprietary Interests of DEWS Membership 68 Procedures for submitting Reviews to the Ocular Surface The 2007 International Dry Eye WorkShop was sponsored by The Tear Film & Ocular Surface Society, which received support for DEWS from SOOFT Italia; Alcon Laboratories; Allergan; McNeil Consumer Healthcare; Pfizer; Santen Pharmaceutical Co.; Bausch & Lomb; Novartis Pharmaceuticals; Advanced Vision Research; Inspire Pharmaceuticals; Vistakon; Senju Pharmaceutical Co.; Kowa; Otsuka Pharmaceutical Co.; Alimera Sciences; Tomei; Nidek The Ocular Surface / April 2007, Vol. 5, No. 2 / 67 DEWS Introduction Introduction to the Report of the International Dry Eye WorkShop (2007) D ry eye disease is a common yet frequently under-recognized clinical condition whose etiology and management challenge clinicians and researchers alike. Advances in the understanding of the disease have been made over the past 10 years in areas of epidemiology, pathogenesis, clinical manifestation, and possible therapy. This volume represents the work of many contributors over a long period of deliberation and through an iterative process that included collection of data, presentation of summary reports in a conference format, and harmonization of reports by a writing team with interactive commentary by the entire group of participants in an international workshop. History In 1994, a workshop sponsored by the National Eye Institute and supported by industry convened a group of scientists, clinicians, and researchers interested in dry eye to clarify the definition and characteristics of dry eye disease and to recommend reliable parameters for conduct of clinical research and conduct of clinical trials for dry eye disease. 1 The report of that workshop has served as a solid resource in the field for over 10 years, but the explosion of information in both basic and clinical research in the interim warranted repetition of the process. An initiative was suggested by Kazuo Tsubota, MD, and endorsed by Michael A. Lemp, MD, to recruit an international panel of experts in dry eye disease to accomplish such a task, and preliminary meetings were held in Selection of the participants was based upon their prior history of peer-reviewed publication, level of participation in previous dry eye meetings (including the NEI/Industry Workshop), and collaboration with acknowledged experts in the field. The immensity of the task became immediately apparent and the coordinating support of The Tear Film & Ocular Surface Society (TFOS) was solicited. David A. Sullivan, PhD, President of TFOS, committed the organizational and administrative support of TFOS and secured broad financial support from international corporations to facilitate the international Dry Eye WorkShop (DEWS). Process The DEWS effort was chaired by Anthony J. Bron, FRCS, and directed by a Steering Committee that proposed guidelines for the determination of acceptable levels of evidence and methods of documentation to support such evidence. The first step involved the formation of subcommittees: Definition and Classification; Epidemiology; Diagnosis; Research; Clinical Trials, and Management and Therapy, in addition to a Communications and Industrial Liaison committee. The scientific subcommittees were charged with identifying contemporary, evidence-based information about various aspects of dry eye disease and summarizing the data in a conceptual format that was well documented and well referenced. Chairpersons of the subcommittees developed goals for each of the working committees and were responsible for coordinating the work. The second step was to hold a 3-day meeting, during which committee reports were presented to the entire group and discussed in an open forum, with all participants invited to comment or suggest additions to the reports. Finally, a writing team was established to review the reports and attempt to harmonize the presentation and cross-reference the information and concepts presented. The process of review and consideration was ongoing over a period of several years. Reports were posted on an internet website for review and commentary by all participants and comments received were submitted to the subcommittee chairpersons for evaluation and response. The draft product was submitted to the Steering Committee for final review and approval. All participants were required to provide disclosures of financial The Ocular Surface / April 2007, Vol. 5, No. 2 / 69 DEWS Introduction continued arrangements or conflicts of interest, and this information is posted on the website (www.tearfilm. org) and published at the end of this issue. Product In addition to the report published in this special issue of The Ocular Surface, the DEWS findings are available in an expanded electronic form on the TFOS website (www.tearfilm.org). This latter provision has allowed the presentation of material excluded from the journal for reasons of space, such as appendices, extended bibliographies, and standardized templates describing diagnostic tests. Each chapter addresses a topic relevant to the understanding of dry eye disease and the combined publication represents a resource that will be valuable to clinicians, epidemiologists, basic and clinical scientists, and members of the pharmaceutical industry. The reader is encouraged to use these resources extensively to support and enhance discussions in the text. Acknowledgements Because the DEWS report represents the integrated work of many participants, individual authorship is not assigned to the overall report or its chapters. Complete listing of the DEWS membership is shown on the following pages, and Subcommittee members are designated in a footnote on the title page of each chapter. Special recognition of the efforts of several participants in the production of this report is appropria
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