Regulation of Contact Lenses and Associated Care Products

Speaker: Denise Hampton, PhD (FDA)

Dr. Hampton received her Bachelor of Science degree in biology from The University of North Carolina at Chapel Hill in 1995. She then began her doctoral studies at the University of Virginia in 1996 and received a Ph.D. in Microbiology in 2004. Dr. Hampton completed a postdoctoral fellowship in the Laboratory of Allergic Diseases at the National Institute of Allergy and Infectious Disease/National Institutes of Health in  2006, after which she accepted the position of Microbiologist in the Division of  Ophthalmic and Ear, Nose and Throat Devices (DOED). Dr. Hampton has been a Branch  Chief of the Contact Lenses and Retinal Devices Branch (CLRD) in DOED since June 2013. 

Preclinical Test Methods for Contact Lenses and their Care Products

Speaker: Jeffrey Brocious, MS (FDA)

Jeffrey Brocious received his Bachelor of Science degree in biology from Virginia Polytechnic Institute in 2000.  He then completed a clinical laboratory science internship at INOVA Fairfax Hospital and received a medical technology (MT) certification from the American Society of Clinical Pathology (ASCP).  He continued to work in the clinical microbiology laboratory while earning a Master of Science degree in Public Health Microbiology and Emerging Infectious Diseases from the George Washington University in 2007.  He served as a supervisor for the Molecular Diagnostics laboratory in the Clinical Center at the National Institutes of Health until April 2013. Mr. Brocious accepted a microbiologist position in 2013 in the Contact Lenses and Retinal Devices Branch (CLRD) in the Division of Ophthalmic and Ear, Nose and Throat Devices (DOED), where he currently works.  

History & Rationale for the Panel of Test Organisms for Contact Lens Care Products

Speaker: Ralph Stone, PhD (Panels 1 & 3)

Dr. Stone has a PhD in chemistry from University of Vermont, and has honorary degree from Southern College of Optometry. He is currently President of R. P. Stone Consulting, Inc. and has been involved in the development and evaluation of contact lens care products for 33 years.  He has held scientific management positions at Bausch and Lomb, Wesley Jessen Corporation and Alcon Laboratories.  He is a member of ANSI and participates on ANSI Z-80 in the development of Contact lens and lens care products. He is a US expert for ISO TC172/SC7/ WG9 on contact lenses and Contact lens care product standards.  He has been recognized by the AOA, the ISCLS and the Arizona Optometric Association for his contributions to the field. He has over 100 patents and publications in the field, and has been a key contributor to the development of many of the current Multi-purpose products in the marketplace.  

PANEL 1: Emerging Pathogens in Contact Lens-Related Keratitis

Moderator: Loretta Szczotka-Flynn, OD (AAO). Panelists: Suzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Mark Willcox, PhD, Jennifer Cope, MD, MPH (CDC), Eduardo Alfonso, MD.

Loretta Szczotka-Flynn, OD, PhD (Moderator)

Dr. Loretta Szczotka-Flynn is Professor at Case Western Reserve University (CWRU) in the Departments of Ophthalmology & Visual Sciences as well as Epidemiology & Biostatistics. She is Director of the Contact Lens Service at the University Hospitals Case Medical Center in Cleveland, Ohio where she has been in practice for over 22 years. She received her Doctorate of Optometry and Masters of Physiological Optics from The Ohio State University in 1992, and her PhD in Epidemiology from Case Western Reserve University in 2009. She is a Diplomate in the Section on Cornea, Contact Lenses and Refractive Technologies of the American Academy of Optometry and she is the Vice-Chair of the Section. 

Eduardo C. Alfonso, M.D. (Panelist)

Eduardo C. Alfonso, M.D., is the Chairman of the Department of Ophthalmology of the University of Miami Miller School of Medicine, director of the Bascom Palmer Eye Institute and holder of the Kathleen and Stanley J. Glaser Chair in Ophthalmology.  Physician, surgeon, professor, administrator and researcher, he is known for his clinical expertise and research in eye diseases, corneal surgery and ocular microbiology.  

He received a Bachelor of Science degree (Summa Cum Laude, Phi Beta Kappa) and medical degree from Yale University. He first arrived at Bascom Palmer Eye Institute in 1981 as an ophthalmology resident.  Following his three-year residency, he completed post-graduate training at Harvard University: a cornea clinical fellowship at the Massachusetts Eye and Ear Infirmary, an ophthalmic pathology fellowship at the David G. Cogan Eye Pathology Laboratory; and a research fellowship at the Howe Laboratory. A board-certified ophthalmologist, Dr. Alfonso joined the Bascom Palmer faculty in 1986 as assistant professor and became tenured professor of ophthalmology and the Edward W.D. Norton Professor in Ophthalmology in 1998.

Dr. Alfonso has served as director of Bascom Palmer since November of 2007 when he was appointed as interim chairman of ophthalmology, and chairman in June 2009. He is an internationally known expert on ocular infectious diseases and he is the medical director of Bascom Palmer Eye Institute’s Ocular Microbiology Laboratory.  His research interests include bacterial and fungal sensitivity. In 2006, he documented an increase in the incidence of an aggressive form of fungal corneal infection that was related to soft contact lens use.  The National Eye Institute, Foundations and philanthropy have funded this research.

Clinically, Dr. Alfonso also specializes in corneal transplants having performed over 1,000 of these in adults and children and he is developing clinical applications of keratoprosthesis, an artificial cornea, which has significant potential for patients awaiting transplants in developing nations where donor tissue is often scarce.

His expertise has led him to be included in the Best Doctors in America by Woodward and White since 1994 and Top Doctors in the United States by Castle Connolly since 2000. He has delivered 18 named lectures. He has been an invited lecturer in over 200 national and international meetings. He serves on the editorial board of ophthalmology journals and has authored more than 300 scientific publications.

Suzi Fleiszig, OD, PhD (Panels 1 & 2)

Dr. Suzanne Fleiszig was educated at the University of Melbourne (Department of Optometry) before moving to the USA in 1991 where she accepted a postdoctoral fellowship at Harvard University. Currently a Professor of Optometry at the University of California, Berkeley, Dr. Fleiszig also holds appointments in the Microbiology, Vision Science, Infectious Diseases & Immunity and the Health & Medical Sciences Programs at UCB, reflecting the interdisciplinary nature of her research. She was Morton D. Sarver Chair between 1997 and 2001, and Associate Dean from 2001-2006. She is an adjunct faculty member of the Proctor Foundation at UC San Francisco.

Dr. Fleiszig has been the recipient of several awards including the Borish Award of the American Academy of Optometry the Glenn Fry Award of the American Optometric Foundation, the Korb Award and Legend’s Award from the American Optometric Association, and the Ruben Medal from the International Society for Contact Lens Research. She has also delivered the George Nissel, Bobier, Hyndiuk, Thygesen and Frontier Lectures. She is a long standing Fellow of the American Academy of Optometry and ARVO, and this year was also elected to Fellowship of the American Academy of Microbiology.

In recent years she has been President of the International Society for Contact Lens Research, Chair of the Immunology and Microbiology Section of the Association for Research in Vision and Ophthalmology, Chair of Division D (Bacteria of Medical Importance) of the American Society for Microbiology, Vice President of the Tear Film and Ocular Surface Society, Chair of the 2012 Cornea Gordon Research Conference, and is currently a Councilor for the American Society for Microbiology. She serves on the editorial boards of The Ocular Surface Journal, Eye and Contact Lens, Investigative Ophthalmology and Visual Science, Infection & Immunity, Frontiers in Cellular and Infection Microbiology, PLoS ONE, and PeerJ. She has also served as a regular member of multiple study sections that review NIH grants proposals in both eye and infectious disease research.

Dr. Fleiszig has authored 90 peer-reviewed publications, most focused on the pathogenesis of contact lens related corneal infection. Her research has been funded by grants from the NIH and the Gates Foundation. In addition to funded contracts, she has also received unrestricted funding from various eye care companies, which has enabled her research to go "off the beaten track".

Causes of Contact Lens-Related Infectious Keratitis in the US: Historical Trends and Emerging Pathogens

Speaker: Jennifer Cope, MD, MPH

Jennifer Cope, MD, MPH is a medical epidemiologist and infectious disease physician with the Waterborne Disease Prevention Branch in the National Center for Emerging and Zoonotic Infectious Diseases. She oversees the free-living ameba program which supports clinical, epidemiologic, laboratory, and communication activities related to the free-living amebae (Naegleria, Balamuthia, Acanthamoeba, and Sappinia).

Dr. Cope began her career at CDC in 2009 as an Epidemic Intelligence Service (EIS) officer assigned to the North Dakota Department of Health. She joined the Waterborne Disease Prevention Branch as a Preventive Medicine Resident in 2011 and transitioned to her current role as medical epidemiologist in 2013.

Dr. Cope obtained a BS in Microbiology from Penn State University and received her medical degree from the University of Pittsburgh School of Medicine. She completed residency training in internal medicine at the Emory University hospitals and Grady Memorial Hospital in Atlanta and infectious disease fellowship training at the University of Maryland Medical Center in Baltimore. She is board certified in both internal medicine and infectious diseases. 

International Patterns of Contact Lens-Related Infectious Keratitis

Speaker: John Dart, MD

Dr. Dart has served as Consultant Ophthalmologist at Moorfields Eye Hospital NHS Foundation Trust (Corneal and External Disease Service) since 1989 and has been Hon. Professor, University College London since 2011.

His educational background includes: BA (Christ Church, Oxford, Zoology) 1971 (MA 1976), BA (Trinity, Cambridge, Medical Sciences) 1973, BM BCh (Oxford University Medical School) 1976 Doctorate: DM (Christ Church, Oxford) 1992. Diplomas: FRCS (Ophthalmology, England) 1982 (Higher Surgical Training Certificate 1983), FRCOphth (England) 1991. Training in iOphthalmology: Residencies at the Oxford Eye Hospital and Moorfields Eye Hospital. Fellowships at the Cullen Eye Institute, Houston (Dr Dan B Jones) and Flinders University, Adelaide (Prof Doug Coster) 1983/4. 

Dr. Dart's professional involvement includes the Fight for Sight Grant Allocation Panel (GAP) 2009-2014. Specialist advisor to National Institute for Clinical Excellence (NICE) Interventional Procedures Programme April 2004 on. Member of Ocular Surface & Inflammation Expert Committee, European Vision Cllnical Research (EVICR) from 2012 on. Member of the Scientific Advisory Board on Avoidable Blindness for The Queen Elizabeth Diamond Jubilee Trust’. For 2 years from April 2013. UCL FLARRE (INFLAMMATION, TISSUE REPAIR, SCARRING AND FIBROTIC DISEASES) Consortium Steering Group Member from 2012 on.

His research interests include: Inflammatory disease of the anterior segment, particularly the conjunctival scarring disorders.  Corneal infectious disease, in particular Acanthamoeba keratitis and contact lens related infection.

The Potential Impact of Environmental Changes on Clinical Acanthamoeba Keratitis

Speaker: Elmer Tu, MD

Elmer Y. Tu, MD is a Professor of Clinical Ophthalmology and the Director of the Cornea and External Disease Section of the Department of Ophthalmology and Visual Sciences, University of Illinois College of Medicine, Chicago, Illinois. He received a BS in Chemistry from the University of Miami in 1984 and an MD from the University of Miami School Of Medicine in 1988. He completed an ophthalmology residency at the University of Wisconsin, Madison in 1992 and a fellowship in Cornea and External Disease at the Bascom Palmer Eye Institute in 1993. He was formerly Director of the Corneal and External Disease Section, Department of Ophthalmology, University of Texas Health Science Center- San Antonio, San Antonio, Texas until 1999 and served as Residency Program Director for a portion of his time there. His area of research interest involves infectious and inflammatory diseases of the ocular surface and corneal surgery.

Dr. Tu is a recipient of the American Academy of Ophthalmology Honor Award and Secretariat Award. He was elected to the Alpha Omega Alpha Honor Society. He serves on the American Academy of Ophthalmology Basic and Clinical Science Course Cornea/External Disease Subcommittee, the AUPO Fellowship Compliance Committee and previously served on the Knowledge Base-Cornea/External Disease-Panel Subcommittee. He is Secretary/Treasurer of the Cornea Society and a Past President of the Ocular Microbiology and Immunology Group. He is an Executive Editor for Cornea and External Diseases for the American Journal of Ophthalmology, and performs peer review on a regular basis for numerous national and international journals. He has also received numerous teaching awards and has been listed as a Best Doctor in America for over 10 years. In total, he has nearly 100 book chapters, peer-reviewed manuscripts, and abstracts in publication.

Michelle C. Callegan, PhD (Panels 1 & 2)

Michelle C. Callegan is a Professor in the Department of Ophthalmology at the University of Oklahoma Health Sciences Center in Oklahoma City. She has been on the OUHSC faculty since 1999 and is also an Adjunct Professor of Microbiology and Immunology and an Associate Director for Research for the Oklahoma Center for Neuroscience. Her research program involves the study of the mechanisms underlying inflammation and vision loss during ocular infections. She is also interested in developing novel therapeutics targeting important bacterial and host pathways during ocular infections. She has a B.S. in microbiology from Louisiana State University, and an M.S. and Ph.D. in microbiology from Louisiana State University Medical Center.

PANEL 2: The Role of Soil in Disinfection Efficacy Testing of Contact Lens Care Products

Moderator: Michael Duenas, OD (AOA). Panelists: Carol Lakkis, PhD, Suzi Fleiszig, OD, PhD, Michelle Callegan, Mark Willcox, PhD,  Ralph Stone, PhD

Michael R. Dueñas, OD (Panel Moderator)

Dr. Michael R. Dueñas serves as the Chief Public Health Officer of the American Optometric Association (AOA). Dr. Dueñas is a graduate of the University of Florida (B.S.) and the University of Alabama, UAB Medical Center - School of Optometry (O.D.).  His work experience includes, bench scientific research, private clinical and hospital based practice, teaching, and applied research with service to the U.S. Centers for Disease Control and Prevention (CDC). Dr. Dueñas currently serves on the PCORI Advisory Panel on Improving Healthcare Systems and testified before the 113th U.S. Congress. Dr. Dueñas’ research interests include public health and epidemiology, linkages between chronic disease and visual impairment, environmental health, risk assessment, disease prevention and measuring access to care to improve quality of life for all people at all life stages.

Carol Lakkis, PhD (Panelist)

Dr. Lakkis is a graduate of the University of Melbourne, Australia, where she was awarded her Bachelor of Science in Optometry in 1991. She then spent her time between clinical practice, contact lens research and clinical teaching for a number of years before continuing her education at the University of California, Berkeley School of Optometry and the University of Melbourne, where she was awarded her PhD in the field of Ocular Microbiology in 1999. Dr. Lakkis then continued to split her time between contact lens research, clinical practice and teaching for twelve years.  She has published over 100 articles and lectured extensively internationally and is recognized internationally as an expert in Ocular Microbiology and Contact Lens Disinfection.  Dr. Lakkis has held academic positions as Fellow and Senior Fellow at the University of Melbourne, Dept of Optometry & Vision Sciences, Assistant Clinical Professor & Assistant Research Scientist, UC Berkeley School of Optometry, USA, and Adjunct Associate Professor, Queensland University of Technology, Australia.  She was Director of Research, Clinical Vision Research Australia, Australian College of Optometry from 2002-2010, and in late 2010 joined Johnson and Johnson Vision Care Research and Development, where she is currently a Clinical Research Fellow and Biological Sciences Leader.  Dr. Lakkis is a Fellow of the American Academy of Optometry, the Australian College of Optometry and the British Contact Lens Association.  Dr. Lakkis is also a Councillor of the International Society of Contact Lens Research and serves on various boards and committees including the editorial board of the journal Eye and Contact Lens, the Tear Film and Ocular Surface Society Corporate Advisory Board, the Association for Research in Vision and Ophthalmology (ARVO) Commercial Relationships Committee and the American National Standards Institute (ANSI) Contact Lens Subcommittee.

Definition of Organic Soil and the Relevant Components of an Artificial Tear Model

Speaker: Mark Willcox, PhD

Professor Willcox’s laboratory focuses on contact lens research, specifically understanding the etiology of adverse events and comfort during contact lens wear. His research includes adhesion and biofilm formation of ocular pathogenic microbes (most notably Pseudomonas aeruginosa) and development of novel antimicrobial surfaces. This research involves the study of microbial pathogenesis, and mammalian tissue responses to microbes and biomaterials. He has established several animal and cell-based models for studying contact lens adverse events and biomaterial infections. His research has encompassed proteomic and lipidomic studies of the tear film and its interaction with contact lenses. He has applied new techniques that allow the quantification individual proteins and lipids that adsorb onto contact lenses, or are biomarkers for changes to the ocular surface. This allows researchers, for the first time, to be able to assess the contribution of particular proteins or lipids to the production of adverse responses during lens wear. He has published over 360 peer reviewed papers during his career and 12 patents. He has trained many graduate students (60 PhD and 2 MSc), 15 postdoctoral and clinical fellows. 

Measuring the Efficacy of Organic Soil Removal

Speaker: Joseph Hutter, PhD (FDA)

Joseph C. Hutter is a chemical engineer with FDA.  At FDA, he has been a reviewer for contact lenses and their care products.  He is interested in improving the pre-market testing of contact lenses and their care products to optimize their performance.  He has also worked in CDRH laboratories on the forensic investigation of medical device failures.  Prior to FDA, he worked on mixed waste treatment at Argonne National Laboratory.  He has a BSChE from University of Florida, and a MS and PhD from Penn State in chemical engineering.  

Incorporating Organic Soil in the Preclinical Testing of Contact Lenses and their Products: Historical Perspective & Current Methods

Speaker: Scott Steffen, PhD (FDA)

LCDR Scott Steffen obtained his BS degree in Biochemistry from the Pennsylvania State University in 1994. He then received his doctoral degree in Biochemistry from the Johns Hopkins Bloomberg School for Public Health where he studied the enzymatic mechanisms of recombinases and other DNA repair enzymes from various bacteria. LCDR Steffen then completed a post-doctoral fellowship in the study of enzymatic mechanisms of various Ebola proteins at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick. He held various research positions investigating potential cancer targets and vaccine candidates at three different biotech companies before joining the Food and Drug Administration in 2008 as a microbiologist in the Center for Drug Evaluation and Research (CDER). He recently accepted a microbiologist position in the Contact Lenses and Retinal Devices Branch in the Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED) in the Center for Devices and Radiological Health (CDRH).

PANEL 3: Acanthamoeba: The Organism and Testing Methods

Moderator: Deepinder Dhaliwal, MD (CLAO), Panelists: Donald Ahearn, PhD, Simon Kilvington, PhD, Elmer Tu, MD, Ralph Stone, PhD, Mary Mowrey-McKee, PhD

Deepinder Dhaliwal, MD (Moderator)

Deepinder K. Dhaliwal MD, L.Ac, is an associate professor at the University of Pittsburgh School of Medicine, Director of Refractive Surgery and the Director of the Cornea Service at the UPMC Eye Center. Dr. Dhaliwal is also the Founder and Director and of the Center for Integrative Eye Care at the University of Pittsburgh. She became a licensed acupuncturist in 2006 and is systematically researching alternative treatments for eye disease.

Dr. Dhaliwal earned her medical degree from Northwestern University in the Honors Program in Medical Education where she was selected as a member of the Alpha Omega Alpha Honor Society, and completed her residency in ophthalmology at the University of Pittsburgh Medical Center.  She completed a fellowship in cornea and refractive surgery at the University of Utah.  She then was invited to join the faculty at the University of Pittsburgh School of Medicine, Department of Ophthalmology and is board-certified by the American Board of Ophthalmology.

Dr. Dhaliwal is a recognized expert in her field and teaches corneal and refractive surgical techniques to other ophthalmologists globally. In addition to teaching and research activities, she is a published author of several book chapters, numerous journal articles, and serves on the editorial board of several ophthalmology journals. In recognition of her clinical and surgical skills, she has been selected as a “Top Doctor” by her peers every year since 2006. 

Mary Mowery-McKee, PhD (Panelist)

Mary Mowery-McKee has been involved in research and development of contact lenses and contact lens care products since 1977. She has participated in a broad range of functional areas including microbiology (disinfection efficacy, preservative efficacy, aseptic filling, sterility testing, adherence of microbes to contact lenses), toxicology (in vitro and in vivo evaluations including assays and assessment of corneal metabolism, ocular up regulation of chemokines/ cytokines in rats), invention of lens care formulations (patents filed on formulations, buffers, systems), analysis of biological molecules (proteins and lipids) on contact lenses, and development of ANSI and ISO standards for contact lenses and lens care.  She has served as the project leader for the development of the following microbiological standards: ISO 14730, ISO 14729, ISO 18259, ISO/DIS 19045 and ISO 19979 as well as ANSI Z80.18 (Ophthalmics - Contact Lens Care Products: Vocabulary, Performance Specifications and Test Methodology).  She has published 18 research papers, holds 14 patents and has given 90 presentations on a variety of topics relevant to contact lenses/lens care.

Acanthamoeba Keratitis: Biology of the Organism and Host Factors

Speaker: Donald Ahearn, PhD 

Donald G. Ahearn PhD is currently a research professor (Emeritus) of microbiology at Georgia State University, Atlanta, Georgia.  He is the author or co-author of over 200 research reports on medically important yeasts and on bacterial and fungal colonization of indoor surfaces and industrial products, including cosmetics, catheters and contact lens materials.  He has been mentor to over 60 MS and PhD students. He is a past-president of the Society for Industrial Microbiology and has served as a member of the Board of Governors of the American Academy of Microbiology and as a Division Officer for the American Society for Microbiology.  He maintains membership in these and other professional societies including the Mycological Society of America, the Contact Lens Association of  Ophthalmologists, the Parenteral Drug Association and the International Society for Human and Animal Mycology.  He has served as a public service consultant to the Centers For Disease Control and as a consultant microbiologist for various pharmaceutical and industrial microbiological laboratories with particular emphasis on mould contamination.  

Disinfection Efficacy Test Methods for Acanthamoeba

Speaker 1: Simon Kilvington, PhD

Simon Kilvington is a Senior Lecturer in the Department of Infection, Immunity and Inflammation at the University of Leicester, England. He completed his PhD from the University Of Bath, England in 1994 through studies on the pathogenic thermophilic free-living amoeba Naegleria fowleri. He has work as a research scientist for the Public Health Laboratory Service (Public Health England) and joined the University of Leicester in 1999. From 2008 to 2012 he was Director of Microbiology at Abbott Medical Optics, California, USA and was elected Research Fellow of the Volwiler Society of Abbott Laboratories. Here he worked on the development Acanthamoeba test methods and improved contact lens disinfection solutions for the global eye care market.

His research interests cover all aspects of microbiology, particularly the Acanthamoeba and their capacity to cause ocular infection, almost exclusively, in contact lens wearers. This includes the development of improved culture and molecular methods for improved taxonomic classification, epidemiological typing and ecological investigations. Research is also concerned with the development of improved therapeutic and disinfectant agents against Acanthamoeba and standardization of assay procedures. The role of biofilm and other factors which determine the presence and survival of Acanthamoeba in tap water systems and the risks this may pose to contact lens wearers is also being studied.

He has published over 100 peer reviewed publications and book chapters and presented his work at numerous international and national conferences. He is an expert member of the British Standards Institute (BSI) and International Organization for Standardization (ISO) committees that address microbiological safety for contact lens care. 

Speaker 2: Daniel Fedorko, PhD (FDA)

Dr. Fedorko earned his Ph.D. from the Medical College of Virginia in 1987.  He spent two years at the Mayo Clinic in a postdoctorate training program in clinical microbiology.  He has been a diplomate of the American Board of Clinical Microbiology since 1991.  He worked as a Staff Scientist in the Microbiology Service in the Department of Laboratory Medicine at the Clinical Center of the National Institutes of Health from 1993 to 2012.  He currently is a microbiologist at the Food and Drug Administration (FDA) in the Diagnostic and Surgical Devices Branch (DSDB) of the Division of Ophthalmic and Ear, Nose and Throat Devices (DOED).