A review of international medical device regulations: Contact lenses and lens care solutions

Zaki, Marina; Pardo, Jesús Francisco Jordá; Carracedo, Gonzalo

doi:10.1016/j.clae.2018.11.001

Cited by 34 publications

(25 citation statements)

References 33 publications

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“…Another problem is the legal regulations related to the registration of contact lenses as a medical device [ 48 ]. It is still not settled whether therapeutic CLs are medical devices, drugs, or a combination of both.…”

Section: Discussionmentioning

confidence: 99%

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Soft Contact Lenses as Drug Delivery Systems: A Review

Rykowska

Nowak

Nowak³

2021

Molecules

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This review describes the role of contact lenses as an innovative drug delivery system in treating eye diseases. Current ophthalmic drug delivery systems are inadequate, particularly eye drops, which allow about 95% of the active substance to be lost through tear drainage. According to the literature, many interdisciplinary studies have been carried out on the ability of contact lenses to increase the penetration of topical therapeutic agents. Contact lenses limit drug loss by releasing the medicine into two layers of tears on either side of the contact lens, eventually extending the time of contact with the ocular surface. Thanks to weighted soft contact lenses, a continuous release of the drug over an extended period is possible. This article reviewed the various techniques to deliver medications through contact lenses, examining their advantages and disadvantages. In addition, the potential of drug delivery systems based on contact lenses has been extensively studied.

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Section: Discussionmentioning

confidence: 99%

“…The commercialisation of DDSCL requires contact lenses with legally compliant physical and chemical properties that provide comfort of use and good vision quality [ 28 , 47 , 48 ].…”

Section: Manufacturing Materialsmentioning

confidence: 99%

Soft Contact Lenses as Drug Delivery Systems: A Review

Rykowska

Nowak

Nowak³

2021

Molecules

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“…Ocular lubricants accounted for 8% of approvals, with the majority of these products gaining MA before 2010. Historically, artificial tears or ocular lubricants have been considered as medicinal products and regulated under the European medicines legislation but, with the more recent introduction of medical devices regulations and amendments to the definitions of medicinal products and devices, such products are now generally classified under devices legislation along with contact lenses and lens care solutions [ 34 – 36 ]. Although it is clear that ocular lubricant eyedrops are intended for the prevention/treatment of symptoms of dry eye, the principle mechanism of action of these products cannot usually be attributed to ‘pharmacological, immunologic or metabolic means’, and thus consequently they are considered as devices rather than medicines for regulatory purposes, and often readily available ‘over-the-counter’.…”

Section: Discussionmentioning

confidence: 99%

Trends in licence approvals for ophthalmic medicines in the United Kingdom

Morgan-Warren¹,

Morarji²

2020

Eye

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Objectives The grant of marketing authorisation (MA) for new medicines requires comprehensive assessment by regulatory authorities. This study sought to identify ophthalmic medicines granted United Kingdom MA and consider trends in licence approvals. Methods This retrospective study reviewed published lists of products granted MA by the UK Medicines & Healthcare products Regulatory Agency between January 2001 and December 2018, inclusive. Eye drops and medicinal products intended for ophthalmic use were identified. All regulatory data sources consulted are in the public domain. Data analyses were descriptive. Results A total of 295 MAs were issued for ophthalmic products between 2001 and 2018, inclusive. Of these 229 (78%) were for single-active substances and 66 (22%) fixed-dose combination (FDC). Approvals for products with single-active substance included ocular hypotensives (115; 50%), antibiotics (48; 22%), allergy medicines (30; 13%), lubricants (18; 8%) and anti-inflammatories (11; 5%). Approvals for FDCs were predominantly ocular hypotensives (56; 85%), with timolol combined with carbonic anhydrase inhibitors (27; 48%) and prostaglandin analogues (26; 46%) accounting for the majority of glaucoma FDCs. Other FDCs were approved for antibiotic/inflammatory (5; 7.5%), pupillary mydriasis (2; 3%), allergy (2; 3%) and ocular surface lubrication (1; 1.5%) products. A median of 16 licences were approved per year (range 7 [2005] to 35 [2011]). Conclusions The majority of MAs granted were for single-agent products, particularly ocular hypotensives and antibiotic preparations. Most products were generic versions of well-established active substances. A trend for increased approvals for FDCs is evident, particularly for the treatment of raised IOP.

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“…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. Later regulatory revisions have since reclassified daily wear soft lenses and rigid corneal lenses as Class II medical devices (moderate to high risk), while overnight and myopia management contact lenses, are considered Class III medical devices [4]. The European Medicines Agency of the European Union, the Australian Therapeutic Goods Administration in Australia, the Drug Controller General of India, and the National Medical Products Administration in China perform a similar function and have similar classification systems for regulating medical devices [4].…”

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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A review of international medical device regulations: Contact lenses and lens care solutions

Cited by 34 publications

References 33 publications

Soft Contact Lenses as Drug Delivery Systems: A Review

Soft Contact Lenses as Drug Delivery Systems: A Review

Trends in licence approvals for ophthalmic medicines in the United Kingdom

BCLA CLEAR – Medical use of contact lenses

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