Latest Food and Drug Administration's Efforts to Improve Safe Contact Lens Use

Hampton, Denise; Tarver, Michelle E.; Eydelman, Malvina B.

doi:10.1097/icl.0000000000000117

Cited by 9 publications

(6 citation statements)

References 9 publications

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“…In May 2014, the FDA Ophthalmic Devices Panel of the Medical Devices Advisory Committee sought input on methods to more accurately test the effect of consumer use on efficacy. 7 , 23 As a result of the advisory committee meeting and other published data demonstrating the negative effects on MPS efficacy by contact lenses and cases, the FDA has indicated that it will revise guidance documents to “further improve the safety of US contact lens users.” 23 , 24 …”

Section: Discussionmentioning

confidence: 99%

Antimicrobial Efficacy of Multipurpose Disinfecting Solutions in the Presence of Contact Lenses and Lens Cases

Gabriel

McAnally

Bartell

2018

Eye &Amp; Contact Lens: Science &Amp; Clinical Practice

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Objective:The aim of this study was to use antimicrobial efficacy endpoint methodology to determine compatibility of multipurpose disinfecting solutions (MPSs), lens cases, and hydrogel lenses for disinfection (AEEMC) against International Organization for Standardization (ISO)–specified microorganisms and clinical ocular isolates of Stenotrophomonas maltophilia.Methods:Six MPSs (PQ/Aldox 1, 2, and 3; PQ/Alexidine; PQ/PHMB; and PHMB) were challenged against ISO-specified microorganisms and S. maltophilia using the AEEMC test. AEEMC tests were performed with and without balafilcon A, etafilcon A, and senofilcon A lenses in lens cases with organic soil. Exposure times included disinfection time (DT) and 24 hr. Additionally, all six MPSs were challenged with two strains of S. maltophilia, based on the ISO Stand-alone test.Results:The efficacy against bacteria for PQ/Aldox and PQ/Alexidine MPSs was not diminished by the presence of lenses. The efficacy of PQ/PHMB and PHMB MPSs against Serratia marcescens was significantly reduced compared with the no-lens control at DT for at least one lens type. The PHMB MPS with lenses present also demonstrated reduced efficacy against Staphylococcus aureus at DT versus the control. PQ/Aldox MPSs retained activity against Fusarium solani with lenses present; however, all other test MPSs demonstrated reduced F. solani efficacy at DT with lenses present. With lenses, all MPSs showed reduced efficacy against Candida albicans.Conclusions:AEEMC antimicrobial efficacy test results vary based on challenge microorganism, contact lenses, and MPS biocide systems. This study highlights the importance of evaluating MPSs for compatibility with lenses and lens cases.

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Section: Discussionmentioning

confidence: 99%

Antimicrobial Efficacy of Multipurpose Disinfecting Solutions in the Presence of Contact Lenses and Lens Cases

Gabriel

McAnally

Bartell

2018

Eye &Amp; Contact Lens: Science &Amp; Clinical Practice

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“…However, these tests do not take into account real-world conditions, such as longer soaking times, the effect of tears, and contact lens uptake and release of solution and tear film components [275,276]. Furthermore, there are currently no requirements for manufacturers to test against Acanthamoeba, albeit such testing is often conducted on a voluntary basis [277,278] and there is an ISO standard to test whether MPDS causes Acanthamoeba encystment (ISO 19045:2015(en) Ophthalmic optics -Contact lens care products -Method for evaluating Acanthamoeba encystment by contact lens care products) [279].…”

Section: Disinfectantsmentioning

confidence: 99%

BCLA CLEAR - Contact lens wettability, cleaning, disinfection and interactions with tears

Willcox

Keir

Maseedupally

et al. 2021

Contact Lens and Anterior Eye

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Contact lens materials have undergone significant changes over the past 20 years, particularly with respect to the introduction of silicone hydrogel materials. Whilst this development addressed hypoxic issues, other important areas relating to contact lens success, notably comfort, require further research.Contact lens wettability remains a crucially important part of biocompatibility. Contact lenses can be made more wettable by incorporation of surfactants into blister packs, internal wetting agents, surface treatments or care solutions. However, there remains no clear association between contact lens wettability and comfort, making it challenging to determine the potential for these approaches to be of significant clinical benefit. Most contact lenses are used on a daily wear, reusable basis, which requires them to be disinfected when not worn. The ideal disinfecting solution would also improve comfort during wear. However, balancing these requirements with other factors, including biocompatibility, remains a challenge. Soft lens materials invariably take up and subsequently release certain components of disinfecting solutions onto the ocular surface. This may affect tear film stability and the normal ocular microbiome, and further research is needed in this area to determine whether this has any affect on comfort. Finally, contact lens materials sorb components of the tear film, and these interactions are complex and may change the biochemistry of the tear film, which in turn may affect their comfort.In conclusion, the interaction between lens materials, tear film and disinfection solution plays an important role in the biocompatibility of lenses. However, the exact role and whether this can be altered to improve biocompatibility and comfort during wear remains debatable. This report summarises the best available evidence to examine this complex relationship and the opportunities for practitioners to enhance in-eye comfort of contemporary lenses, along with providing suggestions for areas of study that may provide further information on this topic.

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“…In the United States (US), mass produced contact lenses are regulated by the US Food and Drug Administration (FDA). The first (hydrogel) soft CL was approved by the US FDA in 1971 as a new drug [2,3]. Contact lenses were later reclassified by the US FDA as Class III medical devices (high risk) in 1976 when the Medical Device Amendment was passed.…”

Section: Regulatory Bodies Labelling and "Therapeutic" Lensesmentioning

confidence: 99%

“…National regulatory bodies take guidance from the International Organisation for Standardization when creating their policies. This body has specifically set international industry standards that are broadly recognised by regulatory agencies throughout the world for lens and care product labelling [2]. They have also set efficacy standards for the care systems needed to maintain contact lenses [5].…”

Section: Regulatory Bodies Labelling and "Therapeutic" Lensesmentioning

confidence: 99%

BCLA CLEAR – Medical use of contact lenses

Jacobs

Carrasquillo²,

Cottrell

et al. 2021

Contact Lens and Anterior Eye

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The medical use of contact lenses is a solution for many complex ocular conditions, including high refractive error, irregular astigmatism, primary and secondary corneal ectasia, disfiguring disease, and ocular surface disease. The development of highly oxygen permeable soft and rigid materials has extended the suitability of contact lenses for such applications. There is consistent evidence that bandage soft contact lenses, particularly silicone hydrogel lenses, improve epithelial healing and reduce pain in persistent epithelial defects, after trauma or surgery, and in corneal dystrophies. Drug delivery applications of contact lens hold promise for improving topical therapy. Modern scleral lens practice has achieved great success for both visual rehabilitation and therapeutic applications, including those requiring retention of a tear reservoir or protection from an adverse environment. This report offers a practical and relevant summary of the current evidence for the medical use of contact lenses for all eye care professionals including optometrists, ophthalmologists, opticians, and orthoptists. Topics covered include indications for use in both acute and chronic conditions, lens selection, patient selection, wear and care regimens, and recommended aftercare schedules. Prevention, presentation, and management of complications of medical use are reviewed.

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Latest Food and Drug Administration's Efforts to Improve Safe Contact Lens Use

Cited by 9 publications

References 9 publications

Antimicrobial Efficacy of Multipurpose Disinfecting Solutions in the Presence of Contact Lenses and Lens Cases

Antimicrobial Efficacy of Multipurpose Disinfecting Solutions in the Presence of Contact Lenses and Lens Cases

BCLA CLEAR - Contact lens wettability, cleaning, disinfection and interactions with tears

BCLA CLEAR – Medical use of contact lenses

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