List of soft contact lens materials

FDA Classification of soft contact lenses

Soft contact lenses are one of several types on the U.S. Market approved by the U.S. Food and Drug Administration[1] for corrective vision eyewear as prescribed by optometrists and ophthamologists.[2] The American Optometric Association published a contact lens comparison chart called Advantages and Disadvantages of Various Types of Contact Lenses on the differences between them.[3] These include:

  • soft contact lenses
  • rigid gas-permeable (RGP)
  • daily wear
  • extended wear
  • disposable and
  • planned replacement contact lenses.

Definition

The U.S. Food and Drug Administration (FDA) states that:

Soft contact lenses are made of soft, flexible plastics that allow oxygen to pass through to the cornea. Soft contact lenses may be easier to adjust to and are more comfortable than rigid gas permeable lenses. Newer soft lens materials include silicone-hydrogels to provide more oxygen to your eye while you wear your lenses.[4]

Types of soft contact lenses

The U.S. Food and Drug Administration (FDA) classifies soft contact lenses into four groups for the U.S. Market. They are also subcategorized into 1st generation, 2nd generation, and 3rd generation lens materials.[5] These 'water-loving' soft contact lens materials are categorized as "Conventional Hydrophilic Material Groups ("-filcon"):

GroupWater ContentPercentageIonic/Non-Ionic
ILow Water Content(<50%)Nonionic
IIHigh Water Content(>50%)Nonionic
IIILow Water Content(<50%)Ionic
IVHigh Water Content(>50%)Ionic

Note: Being ionic in pH = 6.0 - 8.0". This chart was published in the FDA Executive Summary Prepared for the May 13, 2014 Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee.[6]

The FDA has been considering updating soft contact lens group types and related guidance literature.[7][8][9]

Contact lens polymers (hydrogel and silicone hydrogel materials)

The materials that are classified in the 5 FDA groups include the ones listed in the next 5 sections:[10][11]

History

The first contact lenses were made of a polymer called polymethylmethacrylate (PMMA) and became available in the 1960s. Lenses made of PMMA are called hard lenses.[12] Soft contact lenses made of polyacrylamide were introduced in 1971.[12]

FDA groups and brands

Below is a list of most contact lens materials on the market, their water percentage, their oxygen permeability rating, and manufacturer brands.[13] Note that the higher the oxygen permeability rating, the more oxygen gets to the eye.

Group 1 - Low Water (<50% H₂O) Nonionic Polymers

Material% WaterOxygen Permeability (Dk)Brands
Teflicon388.9Cibasoft, Illusions, Torisoft
Tetrafilcon A439CooperToric, Preference, Preference Toric, Vantage
Crofilcon3813CSI, CSI Toric
Hefilcon A4512
Hefilcon B4512
Mafilcom334
Polymacon389Biomedics 38, Edge III, Z4/Z6, Soflens 38
Hioxifilcon B4915Alden SE, Miru
Galyfilcon A4786[14]Acuvue Advance with Hydraclear, Advance for Astigmatism
Lotrafilcon A24140AirOptix Night & Day
Lotrafilcon B33138O2Optix / AirOptix
Senofilcon A38107Acuvue Oasys
Samfilcon A46[15]163[16]Bausch + Lomb Ultra

Group 2 - High Water (>50% H₂O) Nonionic Polymers

Material% WaterOxygen Permeability (Dk)Brands
Surfilcon A7435
Lidofilcon A7031
Lidofilcon B7938
Netrafilcon A6534.5
Hefilcon C57?
Alfafilcon A6632Soflens 66
Omafilcon A5933Proclear, Biomedics Extra, Aveo
Vasurfilcon A7439.1
Hioxifilcon A5936ExtremeH2O 59%, Aura ADM
Hioxifilcon D5421ExtremeH2O 54%
Nelfilcon6926Focus Dailies, Dailies Toric
Hilafilcon A7035Soflens 1-day
Hilafilcon B5922Soflens 59
Nesofilcon A7842Biotrue

Group 3 - Low Water (<50% H₂O) Ionic Polymers

Material% WaterOxygen Permeability (Dk)Brands
Balafilcon A36112/130Purevision, Purevision 2
Bufilcon A4516
Deltafilcon A4310
Phemfilcon389Durasoft 2

Group 4 - High Water (>50% H₂O) Ionic Polymers

Material% WaterOxygen Permeability (Dk)Brands
Bufilcon A5516
Perfilcon A7134
Etafilcon A5828Acuvue, Acuvue Bifocal, Acuvue 2, Acuvue 1-day Moist, Acuvue Define, Colornova, Discon, Waldo, Natural Vue
Focofilcon A5516
Ocufilcon B5316
Ocufilcon C5516
Ocufilcon D5519.7Biomedics 55, Biomedics 55 Premier
Ocufilcon E652
Ocufilcon F6024.3
Phemfilcon A5516Durasoft 3, Freshlook, Wildeyes
Methafilcon A5518Expressions Colors, Frequency 55, Hubble, Revolution, Sunsoft Eclipse, Sunsoft Toric, Vertex Sphere, Vertex Toric
Methafilcon B5518Frequency 55 Toric
Vilfilcon A5516Focus 1-2 Week, Focus Toric, Focus Progressives

Group 5 - Silicone Hydrogel Polymers

Material% WaterOxygen Permeability (Dk)Brands
Delefilcon A33-80
(water gradient)
140Dailies Total1
Narafilcon B4855Acuvue TruEye (old)
Narafilcon A46100Acuvue TruEye (new)
Stenfilcon A54100MyDay

Production generations

There are three generations of silicone hydrogel contact lens materials:[17]

1st Generation2nd Generation3rd Generation
Material:Lotrafilcon A, Balafilcon ASenofilcon A, Galyfilcon ASamfilcon A, Comfilcon A, Enfilcon A
Features:TRIS structures, plasma treated, high modulusModified Tanaka monomer, lack of coatings, higher Dk for water contentNo TRIS structure, no surface treatments or wetting agents, breaks traditional water-Dk-modulus relationships

References

  1. Denise Hampton, Ph.D (13 May 2014). "Contact Lens Safety - Ophthalmic Devices Panel" (PDF). www.fda.gov. FDA Division of Ophthalmic and Ear, Nose and Throat Devices. p. 97. Archived from the original (Microsoft PowerPoint) on 18 Jun 2016.
  2. "About Contact Lenses - clma.net". clma.net. Contact Lens Manufacturers Association. Retrieved 18 June 2016.
  3. "Caring for Your Vision: Advantages and Disadvantages of Various Types of Contact Lenses". www.aoa.org. American Optometric Association. Retrieved 18 June 2016.
  4. Center for Devices and Radiological Health. "Contact Lenses - Types of Contact Lenses". www.fda.gov. U.S. Food and Drug Administration. Retrieved 18 June 2016. This article incorporates text from this source, which is in the public domain.
  5. http://www.aalens.com/fda.html
  6. Ophthalmic Devices Panel of the Medical Devices Advisory Committee (May 13, 2014). "FDA Executive Summary Prepared for the May 13, 2014 Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee" (PDF). U.S. Food and Drug Administration. p. 2. Archived from the original (PDF) on 7 Aug 2015. Retrieved 18 June 2016.
  7. LORETTA B. SZCZOTKA-FLYNN, OD, MS, FAAO (1 Feb 2005). "Contact Lens Materials: Advocating a New Lens Group". Contact Lens Spectrum. Contact Lens Spectrum - February 2005 Issue. Archived from the original (Journal Article) on 6 Oct 2015. Retrieved 18 June 2016.
  8. "Contact Lens Compendium". contactlensupdate.com. Contact Lens Spectrum. Retrieved 18 June 2016.
  9. Tina Kiang, PhD; Joseph Hutter, PhD; J Angelo Green, PhD; K Scott Phillips, PhD; Malvina B Eydelman, MD (10 Nov 2011). "Updating the Contact Lens Classification System" (PDF). www.fda.gov. http://www.fda.gov/cdrh/devadvice: FDA Center of Devices and Radiological Health. p. 38. Archived from the original (PPT) on 17 Nov 2011.
  10. "Contact Lenses: Manufacturing/Chemistry" (PDF). www.fda.gov. U.S. Food and Drug Administration. n.d. p. 25. Archived from the original (PDF) on 15 May 2015. Retrieved 18 June 2016.
  11. "Editorial - Should Silicone Hydrogels be Placed in a Separate FDA Soft Contact Lens Category?". www.siliconehydrogels.org. Retrieved 18 June 2016.
  12. 1 2 "Polymers in everyday things – Contact Lenses" (PDF). rsc.org. Royal Society of Chemistry. Archived from the original (PDF) on 19 June 2016. Retrieved 19 June 2016.
  13. "Contact Lens Materials: Water Content". www.aclens.com. aclens.com. Retrieved 18 June 2016.
  14. Dr. Karen French (12 May 2008). "The Performance of Galyfilcon A" (PDF). OpticianOnline.Net. Contact Lens Monthly. Retrieved 18 June 2016.
  15. AVID L. KADING, OD, FAAO. "New Lens Technology Targets Improved Vision and Comfort: Samfilcon A - Contact Lens Design & Materials". clspectrum.com.
  16. "Product Spectrum: Unsurpassed Comfort and Vision the Goal with Monthly SiHy Lens". clspectrum.com. Contact Lens Spectrum. Retrieved 18 June 2016.
  17. "Looking at Silicone Hydrogels Across Generations". www.optometricmanagement.com. Optometric Management. Retrieved 18 June 2016.
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