328|Alcon Supports New ISO Standard for Real-World Disinfection Testing of Contact Lens Care Products
Nov 14, 2014
Alcon Supports New ISO Standard for Real-World Disinfection Testing of Contact Lens Care Products
FDA and the eye care professional community have highlighted the need for evaluating lens care efficacy in real-world conditions and against clinically relevant pathogens, including Acanthamoeba2
New ISO Standard 18259 advises that contact lens care products be evaluated with organic soil, and in the presence of contact lenses and a lens case3
In a study, using the methodology from ISO Standard 18259, OPTI-FREE® PureMoist® demonstrated better overall disinfection than RevitaLens® and Biotrue® multi-purpose solutions4
FORT WORTH, Texas, November 14, 2014– Alcon, the global leader in eye care, announced today its support for new standards which advise that lens care products be evaluated in accordance with real-world conditions for disinfection.
"We fully support testing of contact lens care products in an environment that accurately reflects patient practice," said Dr. Peter Richardson, Chief Medical Officer at Alcon. "The best way to ensure this is to test our disinfecting solutions in the presence of a contact lens in a contact lens case, and to ensure we are evaluating efficacy against the most relevant pathogens."
Prior standards for lens care products evaluate the intrinsic antimicrobial efficacy of a solution without a contact lens and without assessing how the product will perform when stored in a contact lens case.1 More recently, however, the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and several leading ophthalmology and optometry associations have been evaluating new methods for assessing disinfection efficacy of contact lens solutions in real-world conditions, including disinfection efficacy using contact lenses stored in lens cases.
In September of 2014, FDA co-sponsored a public workshop with the American Academy of Ophthalmology, the American Academy of Optometry, the American Optometric Association, and the Contact Lens Association of Ophthalmologists, Inc. entitled “Revamping Microbiological Testing Methods for Contact Lenses, Products, and Accessories." The discussion included a focus on Acanthamoeba disinfection efficacy, as well as methods for real-world simulated testing of contact lens care products.2
ISO published Standard 18259 in October 2014. The new standard more closely simulates real-world conditions than the prior disinfection efficacy standard, through the addition of organic soil, and by evaluating contact lenses stored in lens cases for various storage times, including the manufacturer-recommended minimum soaking period, at 24 hours, at 7 days, and at the maximum manufacturer-recommended storage period.3
Using the same method described in ISO standard 18259, Alcon compared OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution against RevitaLens® and Biotrue® at the minimum manufacturer-recommended soak time and at 24 hours. Although there are no specific disinfection performance criteria identified for this new ISO Standard, OPTI-FREE® PureMoist® demonstrated better overall disinfection efficacy than the RevitaLens® and Biotrue® multi-purpose solutions.4
References: 1. International Organization for Standardization: ISO:14729. Ophthalmic optics—Contact lens care products—Mircrobiological requirements and test methods for products and regimens for hygienic management of contact lenses. Geneva, Switzerland: 2001(E). 2. FDA, Notice of Public Workshop, 79 FR 49783 (Aug. 22, 2014). 3. International Organization for Standardization: ISO: 18259. Ophthalmic optics—Contact lens care – Method to assess contact lens care product with contact lenses in a case, challenged with bacterial and fungal organisms. Geneva, Switzerland: 2014(E). 4. Effect of Contact Lenses and Lens Cases on Disinfection Efficacy of Four Multipurpose Disinfection Solutions: Gabriel, Manal M; McAnally, Cynthia; Bartell, John; Walters, Rhonda; Spencer, Jebree; Clark, Linda; Catalone, Bradley. IOVS 2013, abstract 520.
About Alcon: Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group, with pro-forma sales of USD 10.5 billion in 2013. Headquartered in Fort Worth, Texas, USA, Alcon has more than 25,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.