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List of soft contact lens materials
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The examples and perspective in this deal primarily with the United States and do not represent a worldwide view of the subject. (November 2020) |
Soft contact lenses are one of several types of contact lenses for corrective vision eyewear as prescribed by optometrists and ophthalmologists.[1]
Background
[edit]It has been suggested that this section be split out and merged into the article titled Contact lens#Soft lenses, which already exists. (Discuss) (January 2022) |
In the US market, soft contact lenses are approved by the US Food and Drug Administration.[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
- planned replacement contact lenses.
The US Food and Drug Administration (FDA) defines soft contact lenses as:
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]
History
[edit]The first contact lenses were made of glass, in 1888. Initially the glass was blown but soon lenses were made by being ground to shape. For the first fifty years, glass was the only material used. The lenses were thin, yet reports of injury were rare. In 1938 perspex (polymethylmethacrylate, or PMMA) began to replace glass in contact lens manufacture. PMMA lenses were easier to produce so the production of glass lenses soon ended. Lenses made of PMMA are called hard lenses.[5] Soft contact lenses were first produced in 1961 by Czech chemical engineer Otto Wichterle using polyhydroxyethylmethacrylate (pHEMA), a material that achieved long-term commercial application. Lenses made of polyacrylamide were introduced in 1971.[5]
Types
[edit]The FDA classifies soft contact lenses into four groups for the US market. They are also subcategorized into 1st generation, 2nd generation, and 3rd generation lens materials.[6] These 'water-loving' soft contact lens materials are categorized as "Conventional Hydrophilic Material Groups ("-filcon"):
| Group | Water Content | Percentage | Ionic/Non-Ionic |
|---|---|---|---|
| I | Low Water Content | (<50%) | Nonionic |
| II | High Water Content | (>50%) | Nonionic |
| III | Low Water Content | (<50%) | Ionic |
| IV | High Water Content | (>50%) | Ionic |
Note: Being ionic in pH = 6.0 – 8.0.[7]
The FDA has been considering updating soft contact lens group types and related guidance literature.[8][9][10]
Contact lens polymers
[edit]The materials that are classified in the 5 FDA groups include the ones listed in the next 5 sections:[11][12]
| FDA lens group | Adopted name | Transmissibility level
(Dk x10-11) |
Water content | Chemical composition |
|---|---|---|---|---|
| I non-ionic low water content |
galyfilcon A | 60 | 47% | – |
| lotrafilcon A | 140 | 24% | DMA, siloxane, TRIS | |
| lotrafilcon B | 110 | 33% | ||
| polymacon | 7.5 | 36% | HEMA | |
| tetrafilcon | 9.0 | 43.5% | HEMA, MMA, NVP | |
| II non-ionic high water content |
alphafilcon A | 22.9 | 66% | HEMA, NVP |
| hilafilcon A | 26.9 | 70% | ||
| omafilcon A | 19.6 | 62% | HEMA, PC | |
| III ionic low water content |
balafilcon A | 99 | 36% | NCVE, NVP, PBVC, TPVC |
| bufilcon A | 16.0 | 45% | DA, HEMA, MAA | |
| IV ionic high water content |
etafilcon A | 17.0 | 58% | HEMA, MAA |
| ocufilcon D | 19.7 | 55% | ||
| vifilcon A | 16.0 | 55% | HEMA, MAA, PVP | |
DA – diacetone acrylamide; DMA – N,N-dimethylacrylamide; HEMA – 2-Hydroxyethyl methacrylate; MAA – methacrylic acid; MMA – methyl methacrylate; NCVE – N-carboxl vinyl ester; NVP – N-vinyl pyrrolidone; PBVC – poly[dimethylsiloxyl] di[silybutanol] bis[vinyl carbamate]; PC – phosphorylcholine; TPVC – tris-(trimethylsiloxysilyl) propylvinyl carbamate; TRIS – tris-(hydroxylmethyl) aminomethane
| ||||
Hydrogel groups
[edit]Below is a list of most contact lens materials on the market, their water percentage, their oxygen permeability rating, and manufacturer brands.[14][15][16][17] Note that the higher the oxygen transmissibility rating, the more oxygen gets to the eye.
Low-water nonionic
[edit]| Material | % Water | Oxygen Transmissibility (Dk/t) | Brands |
|---|---|---|---|
| Tefilcon | 38 | 8.9 | Cibasoft, Illusions, Torisoft, Softint, STD, LL Bifocal |
| Tetrafilcon A | 43 | 9 | Cooper Clear, Cooper Toric, Preference, Preference Toric, Vantage, Vantage Accents, Vantage Thin, Vantage Thin Accents |
| Crofilcon | 38 | 13 | CSI, CSI Toric |
| Helfilcon A/B | 45 | 12 | Continental Toric, Flexlens, Flexlens Toric, Flexlens Aphakic, Optima Toric, All X-Cel lenses |
| Mafilcon | 33 | 4 | Menicon |
| Polymacon | 38.6 | 8.5–24.3 | Allvue, Biomedics 38, Clearview, CustomEyes 38, EpconSOFT, EsstechPS, Esstech PSD, Esstech SV, Frequency 38, HD, HD-T, HDX, HDX-T, Horizon 38, Hydron Mini, Hydron Zero 4 SofBlue, Hydron Zero 6 SofBlue, Hydron Versa Scribe, Lifestyle MV2, Ideal Soft, Lifestyle Xtra, Lifestyle 4Vue, Lifestyle Toric Bifocal, LL38, Metrosoft ll Multifocal, Metrosoft Toric, Natural Touch, Occasions, Optima 38/SP, PS-45 Multifocal, Simulvue 38, Sof-form II, SofLens, SofLens38, SofLens Multi-Focal, Softics, SoftView, Unilens 38, Westhin Toric, EZvue Soft Contact Lens, Solotica |
| Hioxifilcon B | 49 | 15 | Alden HP Sphere, Alden HP Toric, Aquaease, Essential Soft Toric Multifocal, Flexlens, Quattro, Satureyes, Satureyes Toric and Multifocal, All X-Cel Lenses |
High-water nonionic
[edit]| Material | % Water | Oxygen Transmissibility (Dk/t) | Brands |
|---|---|---|---|
| Surfilcon A | 74 | 35 | |
| Lidofilcon A | 70 | 31 | ActiFresh 400, CV 70 |
| Lidofilcon B | 79 | 38 | |
| Netrafilcon A | 65 | 34.5 | |
| Hefilcon B | 45 | 10 | Optima Toric |
| Alphafilcon A | 66 | 32 | SofLens Toric for Astigmatism |
| Omafilcon A | 58–60 | 28–36.7 | Proclear 1-Day, Proclear EP, Proclear 1 day Multifocal, Proclear Multifocal Toric, Biomedics XC, Aveo |
| Omafilcon B | 62 | 21.3–52.3 | Proclear Sphere, Proclear toric, Proclear toric XR, Proclear multifocal, Proclear multifocal XR, Proclear multifocal toric |
| Vasurfilcon A | 74 | 39.1 | Precision UV |
| Hioxifilcon A | 59 | 28 | Alden HP Sphere, Alden HP Toric, ExtremeH₂O 59% Thin/Extra, Biocurve Gold Sphere and Toric, Aura ADM, Scout by Warby Parker,[18] Hydro by Hubble, Miru 1 Day[19] |
| Hioxifilcon D | 54 | 21 | Alden HP Sphere, Alden HP Toric, ExtremeH₂O 54%, Clarity H₂0, C-Vue Advanced Custom Toric |
| Nelfilcon A | 69 | 26 | Focus Dailies, Focus Dailies Toric/Progressive, Dailies AquaComfort Plus, FreshLook One-Day, Synergy, Triton |
| Hilafilcon A | 70 | 35 | |
| Hilafilcon B | 59 | 22 | SofLens 59, SofLens Daily Disposable, SofLens Daily Disposables for Astigmatism |
| Acofilcon A | 58 | 25.5 | Flexlens Tricurve Keratoconus |
| Nesofilcon A | 78 | 42 | Biotrue ONEday |
Low-water ionic
[edit]| Material | % Water | Oxygen Transmissibility (Dk/t) | Brands |
|---|---|---|---|
| Bufilcon A | 45 | 16 | Hydrocurve II 45, Soft Mate B |
| Deltafilcon A | 43 | 10 | Amsoft, Amsoft Thin, Comfort Flex, Custom Flex, Metrosoft, Soft Form Toric |
| Phemfilcon | 38 | 9 | Durasoft 2 |
High-water ionic
[edit]| Material | % Water | Oxygen Transmissibility (Dk/t) | Brands |
|---|---|---|---|
| Bufilcon A | 55 | 16 | Hydrocurve I, Hydrocurve 3 Toric, Softmate II |
| Perfilcon A | 71 | 34 | Permalens |
| Etafilcon A | 58 | 23.8–28 | Acuvue, Acuvue Bifocal, Acuvue 2, Acuvue 2 Colors, 1-Day Acuvue, 1-Day Acuvue Moist, 1-Day Acuvue Moist for Astigmatism, 1-Day Acuvue Moist Multifocal, 1-Day Acuvue Define, Colornova, Discon, Waldo, Natural Vue, Ocylens |
| Focofilcon A | 55 | 16 | Fre-Flex |
| Ocufilcon B | 52–53 | 16–24 | ClearSight 1-Day, Continental, Ocu-Flex 53 |
| Ocufilcon C | 55 | 16 | UCL55, UCL-Pediatric |
| Ocufilcon D | 55 | 17.8–28.1 | Biomedics 55 Premier asphere, Biomedics Toric, ClearSight 1-Day Toric, Horien 1-Day Disposable |
| Ocufilcon E | 65 | 22 | Ocuflex 65 |
| Ocufilcon F | 60 | 24.3 | Hydrogenics 60 UV |
| Phemfilcon A | 55 | 16 | Durasoft 3, Freshlook, Wildeyes |
| Methafilcon A | 55 | 17.9-37.6 | Biocurve Advanced Aspheric, Biocurve 1-Day, Biocurve Toric & Sphere, C-Vue 1-Day ASV, C-Vue 55, Edge III 55, Elite AC, Elite Daily, Elite AC Toric, Expressions Colors, Flexlens, Frequency 55 Sphere/Multifocal, HD2, HDX2, Horizon 55 Bi-Con, Hubble, Kontur, LL55, New Horizons, Revolution, Sauflon 55, Sof-form 55, Sunsoft Eclipse, Sunsoft Toric, Vertex Sphere, Vertex Toric |
| Methafilcon B | 55 | 14.5–31.3 | Frequency 55 Toric, Hydrasoft Sphere, Hydrasoft Sphere Thin, Hydrasoft Aphakic, Hydrasoft Aphakic Thin, Hydrasoft Toric, Hydrasoft Toric Thin |
| Vilfilcon A | 55 | 16 | Focus 1–2 Week Softcolors, Focus Monthly Softcolors, Focus Toric, Focus Progressives, Soft 55, Soft 55 EW |
Silicone hydrogel polymers
[edit]| Material | FDA Group | % Water | Oxygen Transmissibility (Dk/t) | Modulus (MPa) | Center Thickness (mm) | Brands |
|---|---|---|---|---|---|---|
| Lotrafilcon A | 1 | 24 | 175[20] | 1.5 | 0.08 | Air Optix Night & Day Aqua |
| Lotrafilcon B | 1 | 33 | 110–138 | 1.0 | 0.08 | O2Optix, Air Optix for Astigmatism, Air Optix Aqua, Air Optix Aqua Multifocal, Air Optix Colors |
| Galyfilcon A | 1 | 47 | 86[21] | 0.43 | 0.07 | Acuvue Advance with Hydraclear, Acuvue Advance for Astigmatism |
| Senofilcon A | 1 | 38 | 103–147 | 0.7 | 0.07 | Acuvue Oasys, Acuvue Oasys for Astigmatism, Acuvue Oasys for Presbyopia, Acuvue Oasys 1-Day, Acuvue Oasys 1-Day for Astigmatism, Acuvue Oasys with Transitions, Acuvue Oasys Max 1-Day, Acuvue Oasys Max 1-Day Multifocal |
| Senofilcon C | 41 | 129–147 | 0.77 | 0.07 | Acuvue Vita, Acuvue Vita for Astigmatism | |
| Sifilcon A | 1 | 32 | 82 | 0.08 | O2Optix Custom | |
| Comfilcon A | 1 | 48 | 116–160 | 0.75 | 0.08 | Biofinity, Biofinity toric, Biofinity XR, Biofinity XR toric, Biofinity Energys, Biofinity multifocal |
| Enfilcon A | 1 | 46 | 100 | 0.6 | 0.06 | Avaira, Avaira Toric |
| Balafilcon A | 3 | 36 | 91-130 | 1.1 | 0.09 | PureVision, PureVision Toric, PureVision Multi-Focal, PureVision2, PureVision2 for Astigmatism, PureVision2 Multi-Focal for Presbyopia |
| Delefilcon A | 33–99 (water gradient) |
156[22] | 0.7 | 0.09 | Dailies Total1, Dailies Total1 Multifocal, DailiesTotal1 for Astigmatism | |
| Narafilcon B | 1 | 48 | 55 | 1-Day Acuvue TruEye (old) | ||
| Narafilcon A | 46 | 118 | 0.66 | 0.085 | 1-Day Acuvue TruEye (new) | |
| Stenfilcon A | 54 | 80–100 | 0.4 | 0.08 | MyDay, MyDay toric, MyDay Multifocal, Kirkland Signature | |
| Somofilcon A | 56 | 57–86 | 0.5 | 0.07 | Clariti 1 day, Clariti 1 day toric, Clariti 1 day multifocal, Live daily disposable | |
| Fanfilcon A | 55 | 90–110 | 0.6 | 0.06 | Avaira Vitality, Avaira Vitality toric, 24H Toric | |
| Samfilcon A | 46[23] | 163[24] | 0.7 | 0.07 | Bausch & Lomb Ultra, Bausch & Lomb Ultra for Astigmatism, Bausch & Lomb Ultra for Presbyopia | |
| Elastofilcon | 0.2 | 340 | SilSoft Aphakic, SilSoft Super Plus | |||
| Kalifilcon A | 55 | 134[25] | 0.5 | 0.08 | Bausch & Lomb INFUSE | |
| Asmofilcon A | 40 | 161[26] | 0.9 | 0.08 | Miru 1month | |
| Verofilcon A | 51–80 (water gradient) |
100 | 0.6 | 0.09 | Alcon Precision1, Alcon Precision1 for Astigmatism | |
| Lehfilcon A | 55–99 (water gradient) |
154[27] | 0.6 | 0.08 | Total30 | |
| Olifilcon B | 47 |
120[28] | 0.6 | 0.08 | Kits Daily, Everclear Elite, Hubble SkyHy | |
| Olifilcon A | 47 |
150[29] | 0.6 | 0.08 | Everclear Plus, Everclear Air |
Production generations
[edit]There are three generations of silicone hydrogel contact lens materials:[30]
| 1st Generation | 2nd Generation | 3rd Generation | |
|---|---|---|---|
| Material: | Lotrafilcon A, Balafilcon A | Senofilcon A, Galyfilcon A | Samfilcon A, Comfilcon A, Enfilcon A, Asmofilcon A[31] |
| Features: | TRIS structures, plasma treated, high modulus | Modified Tanaka monomer, lack of coatings, higher Dk for water content | No TRIS structure, no surface treatments or wetting agents, breaks traditional water-Dk-modulus relationships |
References
[edit]- ^ "About Contact Lenses - clma.net". clma.net. Contact Lens Manufacturers Association. Retrieved 18 June 2016.
- ^ 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 June 2016.
- ^ "Caring for Your Vision: Advantages and Disadvantages of Various Types of Contact Lenses". www.aoa.org. American Optometric Association. Retrieved 18 June 2016.
- ^ Center for Devices and Radiological Health. "Contact Lenses - Types of Contact Lenses". www.fda.gov. U.S. Food and Drug Administration. Archived from the original on June 5, 2009. Retrieved 18 June 2016.
This article incorporates text from this source, which is in the public domain.
- ^ a b "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.
- ^ "The FDA has created the 4 Lens groups of hydrogels Materials to clarify categories of similar polymers for investigating solutions approvals". Archived from the original on 2016-08-10. Retrieved 2016-06-28.
- ^ "FDA Executive Summary Prepared for the May 13, 2014 Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee" (PDF). Ophthalmic Devices Panel of the Medical Devices Advisory Committee. U.S. Food and Drug Administration. May 13, 2014. p. 2. Archived from the original (PDF) on 7 August 2015. Retrieved 18 June 2016.
- ^ Loretta B. Szczotka-Flynn (February 2005). "Contact Lens Materials: Advocating a New Lens Group". Contact Lens Spectrum. Archived from the original on 6 October 2015. Retrieved 18 June 2016.
- ^ "Contact Lens Compendium". contactlensupdate.com. Contact Lens Spectrum. Retrieved 18 June 2016.
- ^ Tina Kiang; Joseph Hutter; J Angelo Green; K Scott Phillips; Malvina B Eydelman (10 Nov 2011). "Updating the Contact Lens Classification System" (PDF). Food and Drug Administration. Archived from the original (PDF) on 17 November 2011.
- ^ "Contact Lenses: Manufacturing/Chemistry" (PDF). www.fda.gov. U.S. Food and Drug Administration. n.d. p. 25. Archived from the original (PDF) on 1 May 2015. Retrieved 18 June 2016.
- ^ "Editorial - Should Silicone Hydrogels be Placed in a Separate FDA Soft Contact Lens Category?". www.siliconehydrogels.org. Retrieved 18 June 2016.
- ^ Stretton, Serina (October 2004). "Should Silicone Hydrogels be Placed in a Separate FDA Soft Contact Lens Category?". siliconehydrogels.org. Retrieved 3 September 2020.
- ^ "Contact Lens Spectrum - Soft Contact Lenses". www.clspectrum.com. Contact Lens Spectrum. Retrieved 19 Feb 2019.
- ^ "CooperVision Product Reference Guide - 2019" (PDF). coopervision.com. CooperVision. Retrieved 19 Feb 2019.
{{cite web}}: CS1 maint: url-status (link) - ^ "Acuvue Tech Specs - Winter 2017" (PDF). www.acuvue.com. Johnson & Johnson. Retrieved 19 Feb 2019.
- ^ "Contact Lenses: Bausch + Lomb". www.bausch.com. Bausch & Lomb. Retrieved 19 Feb 2019.
- ^ "Scout by Warby Parker (90 Pack) Contacts". Warby Parker.
- ^ "Miru 1 Day Contacts". LensPricer.
- ^ "10.2.4 AONDA Product Page | MyAlcon".
- ^ Dr. Karen French (12 May 2008). "The Performance of Galyfilcon A" (PDF). OpticianOnline.Net. Contact Lens Monthly. Retrieved 18 June 2016.
- ^ "Dailies TOTAL1® Lens Parameters and Fitting Guide | Alcon".
- ^ David L. Kading (May 2014). "New Lens Technology Targets Improved Vision and Comfort". Contact Lens Spectrum. Vol. 29.
- ^ Lens Parameters pi.bausch.com Retrieved 30 March 2023
- ^ "Bausch + Lomb INFUSE - Optix-now". Optix-now - Your Vision Care Guide. Retrieved 2020-12-23.
- ^ "Miru 1month | Menicon America". Menicon America. Retrieved 2021-05-01.
- ^ "TOTAL30® Parameters and Contact Lens Technology | Alcon".
- ^ "K180322 - Trade/Device Name: Si-Hy (olifilcon B) color silicone hydrogel soft contact lens" (PDF). Archived from the original (PDF) on 2021-05-15.
- ^ K183670 - Trade/Device Name: Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses
- ^ "Looking at Silicone Hydrogels Across Generations". www.optometricmanagement.com. Optometric Management. Retrieved 18 June 2016.
- ^ Carnt, Nicole (May 2008). "3rd Generation Silicone Hydrogel Lenses". www.siliconehydrogels.org. Retrieved 5 October 2021.
List of soft contact lens materials
View on GrokipediaBackground
Historical Development
The development of soft contact lens materials originated in the late 19th century with Adolf Fick's invention of the first functional contact lens in 1888, a large glass scleral design intended to correct severe astigmatism by resting on the sclera rather than the cornea.[8] This early prototype, though uncomfortable and limited to short wear times, laid the groundwork for subsequent innovations in ocular correction. In 1936, Czech chemist Otto Wichterle advanced the field by creating the first rigid contact lenses from polymethyl methacrylate (PMMA), a transparent plastic that offered greater durability and lighter weight than glass, enabling corneal rather than scleral fitting.[9] The breakthrough for soft lenses occurred in 1961 when Wichterle, collaborating with Drahoslav Lim, developed the first prototype using poly(2-hydroxyethyl methacrylate) (pHEMA), a hydrophilic polymer capable of absorbing up to 40% water to mimic the eye's natural moisture and improve comfort.[10] This hydrogel material allowed lenses to conform flexibly to the cornea, reducing irritation associated with rigid designs. Commercialization followed in 1971 with FDA approval of Bausch & Lomb's Soflens, the first mass-produced soft lens made from polymacon (a pHEMA variant), which rapidly gained popularity for daily wear despite initial challenges in manufacturing and durability.[11] Key advancements in the 1980s included the introduction of high-water content hydrogels (over 50% water), which enhanced wearer comfort and initial oxygen flow to the cornea, alongside the FDA's establishment of a four-group classification system for these materials based on water content and ionic properties.[12] By the late 1990s, limitations in oxygen permeability of traditional hydrogels prompted the integration of silicone into hydrogel formulations, creating silicone hydrogels that significantly improved gas transmissibility while maintaining softness.[13] The first such lens, lotrafilcon A (used in CIBA Vision's Focus Night & Day), received FDA approval in 1998, enabling safer extended wear.[12] The early 2000s saw further growth in extended wear capabilities, highlighted by the 2001 FDA approval of the Night & Day lens for up to 30 nights of continuous use, reducing risks of hypoxia-related complications.[11] As of 2025, over 25 years after the commercialization of silicone hydrogels, these materials had become predominant, accounting for approximately 75% of new soft lens fittings worldwide due to their superior performance in daily and overnight applications.[6]Key Properties and Metrics
Soft contact lens materials are evaluated based on several core physical properties that influence their performance, safety, and user comfort. Water content, expressed as the percentage of water in the fully hydrated lens, typically ranges from 30% to 80% and plays a critical role in determining lens flexibility, oxygen transport to the cornea, and overall wearing comfort; higher water content generally enhances comfort by improving conformability to the eye but can increase evaporative dehydration if not balanced with adequate oxygen permeability. Another related metric is the pervaporation rate, which quantifies the evaporation of water from the ocular environment through the contact lens, combining permeation and evaporation processes. While useful for assessing evaporation-related comfort, particularly at low humidity, the pervaporation rate has limitations when comparing contact lenses: it addresses only dehydration-induced discomfort and does not encompass overall performance or eye health; oxygen transmissibility (Dk/t) is more critical for preventing complications such as corneal edema and hypoxia; other factors, including surface wettability, elastic modulus, deposition resistance, and on-eye dehydration kinetics, also significantly influence comfort; furthermore, in vitro measurements do not always predict real-world performance due to variations in tear composition, blink rate, and environmental conditions.[14][15] Materials are further classified as ionic or nonionic depending on the presence of charged functional groups, such as sulfonic or carboxylic acids in ionic hydrogels, which attract oppositely charged proteins and lipids from the tear film, leading to higher deposition risks and potential discomfort or reduced lens lifespan in ionic types compared to nonionic ones.[16] Oxygen permeability is a key metric for ensuring corneal health, quantified by the Dk value, which measures the intrinsic ability of the material to transmit oxygen and is expressed in barrer units, where 1 barrer equals 10^{-11} (cm³ STP·cm)/(cm²·s·cmHg).[17] The effective oxygen transmissibility, Dk/t, accounts for lens thickness (t in cm) and is reported in barrers/cm, with values above 24 typically recommended for daily wear to minimize corneal edema and hypoxia, though higher thresholds like 87 are advised for extended wear to prevent overnight swelling.[18] This shift toward higher Dk materials became prominent in the 1990s to address limitations in traditional hydrogels.[19] Mechanical properties, including the elastic modulus, assess the material's stiffness and handling characteristics, with lower values (often 0.3–1.0 MPa or approximately 40–145 psi) preferred for enhanced on-eye comfort and reduced lid interaction during blinking.[20] Wettability, evaluated via the contact angle formed between the lens surface and a saline droplet, indicates tear film stability; advancing contact angles below 90° signify good surface hydration and lipid resistance, preventing dryness and deposits that could impair vision.[21] The U.S. Food and Drug Administration (FDA) groups hydrogel materials into four categories based on water content and ionicity to guide biocompatibility and care recommendations: Group I (low water, <50%, nonionic) offers low deposition but limited oxygen flow; Group II (high water, >50%, nonionic) balances comfort and moderate permeability; Group III (low water, ionic) offers similar oxygen permeability to Group I but higher protein buildup; and Group IV (high water, ionic) maximizes hydration yet poses the greatest deposition risk, often requiring enzymatic cleaners.[22] These properties are standardized under ISO 18369, which outlines measurement protocols for parameters like water content (via gravimetric methods), Dk (polarographic or coulometric techniques), modulus (tensile testing), and contact angle (goniometry), ensuring consistent evaluation across materials.[23]Hydrogel Groups
Low-Water Nonionic (Group I)
Low-water nonionic soft contact lenses, classified as FDA Group I, feature water contents below 50% and lack ionic charges in their polymer structure, which minimizes attraction to lipids and proteins from the tear film.[24] This composition makes them particularly suitable for sensitive eyes, as they exhibit reduced buildup of deposits compared to ionic or higher-water materials.[24] Key materials in this group include polymacon, hefilcon A, and tetrafilcon A, each offering distinct mechanical and optical properties tailored for daily wear. Polymacon, a copolymer primarily based on 2-hydroxyethyl methacrylate (HEMA), has a water content of 38.6% and oxygen transmissibility (Dk/t) ranging from 8.5 to 24.3, depending on lens power and thickness, with a modulus of approximately 0.8 MPa that contributes to its firmness.[25] Hefilcon A, composed of HEMA and N-vinyl-2-pyrrolidone (NVP), provides 42% water content and Dk/t values between 10 and 20, balancing hydration with structural integrity.[26] Tetrafilcon A, a terpolymer of HEMA, NVP, and methyl methacrylate, achieves 43.5% water content with a Dk of around 9, supporting moderate oxygen flow while maintaining lens stability. These materials offer high durability and resistance to deformation, making Group I lenses ideal for first-time wearers who require straightforward handling and minimal maintenance.[24] Their nonionic nature also slows dehydration in dry environments, reducing discomfort for users with mild dry eye symptoms.[27] However, the lower water content results in reduced oxygen permeability relative to high-water groups, potentially limiting extended wear suitability and necessitating careful monitoring for corneal health.[24] Commercial examples include Bausch + Lomb's SofLens 38 lenses made from polymacon, often prescribed for biweekly or monthly replacement schedules to optimize hygiene and comfort.[25] Older formulations of CooperVision's Focus and Precision brands utilized tetrafilcon A or similar Group I polymers, typically on monthly cycles, while hefilcon A appears in specialty tinted lenses like Saview-Colors Aqua 42 UV, suited for similar replacement intervals.[26][28]High-Water Nonionic (Group II)
High-water nonionic soft contact lenses, classified as FDA Group II, feature a water content exceeding 50% and lack ionic charges, enabling enhanced hydration for wearer comfort while minimizing protein deposition compared to ionic counterparts.[2] These materials strike a balance by offering superior initial comfort through increased flexibility and moisture retention, though they may dehydrate more rapidly in low-humidity environments due to their elevated water levels.[29] Key examples of Group II materials include nelfilcon A, omafilcon A, and nesofilcon A, all nonionic hydrogels designed for daily wear. Nelfilcon A, found in Dailies AquaComfort Plus, exhibits a higher water content of 69% with a Dk/t of 26 at -3.00D, prioritizing surface hydration via polyvinyl alcohol crosslinking.[30] Omafilcon A, used in Proclear lenses, has 62% water content, a Dk/t of 51 at -3.00D, and a modulus of 0.6 MPa, providing good oxygen flow and resistance to dehydration.[31] Nesofilcon A, in Biotrue ONEday, achieves 78% water content with a Dk of 42, emphasizing high hydration mimicking the tear film for all-day comfort.[32]| Material | Water Content | Dk/t (at -3.00D) | Modulus (MPa) | Example Lens |
|---|---|---|---|---|
| Nelfilcon A | 69% | 26 | Not specified | Dailies AquaComfort Plus |
| Omafilcon A | 62% | 51 | 0.6 | Proclear |
| Nesofilcon A | 78% | 60 | Not specified | Biotrue ONEday |
Low-Water Ionic (Group III)
Low-water ionic soft contact lens materials, classified as FDA Group III, consist of hydrogels with less than 50% water content and ionic components, often incorporating charged groups such as those derived from methacrylic acid to facilitate water binding at physiological pH. These materials exhibit a higher propensity for protein deposition compared to nonionic counterparts due to electrostatic interactions with tear proteins, but they demonstrate robust mechanical strength, making them suitable for durable lens designs that withstand handling and wear. Oxygen transmissibility (Dk/t) in these materials typically ranges from 10 to 20, supporting moderate oxygen needs for daily wear and select extended wear scenarios without excessive corneal stress.[36][37][38] Representative examples of Group III materials include crofilcon and lidofilcon B, both with low water contents around 38%, offering balanced properties for extended wear applications. Crofilcon, used in older lenses like CSI, has a Dk/t of 13 and modulus approximately 1.0 MPa, providing good durability for astigmatism correction. Lidofilcon B features a Dk/t of about 18, contributing to its use in lenses requiring moderate breathability. These properties position Group III materials for monthly replacement schedules and toric designs addressing astigmatism.[24][38]| Material | Water Content (%) | Dk/t | Modulus (MPa) | Example Lenses |
|---|---|---|---|---|
| Crofilcon | 38 | 13 | 1.0 | CSI, CSI Toric (older extended wear) |
| Lidofilcon B | 38 | 18 | N/A | Biomedics-related designs |
High-Water Ionic (Group IV)
High-water ionic soft contact lenses, classified by the FDA as Group IV, are hydrogel materials containing more than 50% water by weight and incorporating ionic monomers such as methacrylic acid, which impart a negative charge to the polymer.[2][40] These lenses are particularly suited for wearers with dry eyes, as the elevated water content enhances initial comfort and wettability upon insertion, mimicking the eye's natural moisture levels.[29] However, the ionic nature combined with high hydration makes them susceptible to greater protein and lipid deposition from the tear film, necessitating rigorous cleaning regimens and often limiting their use to daily or short-term replacement schedules.[41] Representative materials in this group include etafilcon A and ocufilcon D, which exemplify the balance of softness and oxygen transmission typical of Group IV polymers. Etafilcon A, a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), features 58% water content and an oxygen transmissibility (Dk/t) of 28 at -3.00D, with a low modulus of approximately 0.5 MPa contributing to its supple feel.[38][42] Ocufilcon D, used in daily disposable formats like Biomedics 55, has 55% water content and a Dk/t of 28 at -3.00D, offering similar ionic characteristics with balanced oxygen flow.[43][44]| Material | Water Content (%) | Dk/t (at -3.00D) | Modulus (MPa) | Key Features |
|---|---|---|---|---|
| Etafilcon A | 58 | 28 | ~0.5 | High wettability, UV protection; prone to deposits |
| Ocufilcon D | 55 | 28 | ~0.6 | Daily disposable compatible; balanced comfort |
Silicone Hydrogel Polymers
First Generation
The first generation of silicone hydrogel materials, introduced between 1998 and 2003, represented a pivotal advancement by integrating silicone components, such as tris(trimethylsiloxy)silyl propyl methacrylate (TRIS), with traditional hydrogel polymers to achieve significantly higher oxygen permeability (Dk) while maintaining sufficient hydration for comfort. These materials typically featured water contents ranging from 24% to 36% and were characterized by relatively high mechanical stiffness, with moduli exceeding 1.0 MPa, which contributed to their durability but also posed handling challenges. Developed primarily by CIBA Vision (now Alcon) and Bausch & Lomb, these lenses addressed the oxygen limitations of conventional hydrogels, enabling safer extended wear schedules. FDA approvals for daily wear began in 1997, with extended wear clearances following in 2001 for key products. Key examples include lotrafilcon A, used in Focus Night & Day (later Air Optix Night & Day Aqua) lenses by CIBA Vision, which has a 24% water content, Dk of 140 barrers, Dk/t of approximately 140, and modulus of 1.2 MPa. Balafilcon A, employed in Bausch & Lomb's PureVision lenses, offers 36% water content, Dk of 91 barrers, Dk/t of 99, and modulus of 1.1 MPa. These materials were the first to support true extended wear up to 30 continuous days, reducing hypoxia-related complications like corneal swelling compared to traditional hydrogels. However, their higher modulus and hydrophobic silicone surfaces often led to reduced wettability, increasing risks of ocular dryness and giant papillary conjunctivitis (GPC) due to mechanical irritation and protein deposition.| Material | Water Content (%) | Dk (barrers) | Dk/t | Modulus (MPa) | Example Brand | FDA Approval Year (Extended Wear) |
|---|---|---|---|---|---|---|
| Lotrafilcon A | 24 | 140 | 140 | 1.2 | Focus Night & Day | 2001 |
| Balafilcon A | 36 | 91 | 99 | 1.1 | PureVision | 2001 |
Second Generation
The second generation of silicone hydrogel contact lenses emerged between 2004 and 2008, building on the high oxygen permeability of first-generation materials by incorporating internal wetting agents or surface coatings to enhance biocompatibility while maintaining Dk/t values in the range of 80 to 150. These lenses typically featured water contents around 33% to 47%, with reduced modulus compared to earlier silicone hydrogels to improve lens flexibility and wearer comfort. Key innovations included the use of hydrophilic polymers like polyvinylpyrrolidone (PVP) as internal wetting agents, which migrated to the lens surface to promote tear film stability and reduce lipid deposition. Representative materials from this generation include senofilcon A, galyfilcon A, and lotrafilcon B, each developed by major manufacturers to address the stiffness and dryness issues of prior designs. The following table summarizes their core properties:| Material | Brand Example | Water Content (%) | Dk/t (at -3.00D) | Modulus (MPa) |
|---|---|---|---|---|
| Senofilcon A | Acuvue Oasys (Johnson & Johnson) | 38 | 147 | 0.7 |
| Galyfilcon A | Acuvue Advance (Johnson & Johnson) | 47 | 86 | 0.6 |
| Lotrafilcon B | Air Optix (Alcon) | 33 | 138 | 0.75 |
Third Generation
The third generation of silicone hydrogel materials emerged around 2009, building on prior innovations by incorporating higher water contents of 46-80% and advanced smart surface designs, such as water gradients, to improve wettability and reduce end-of-day discomfort without relying on external coatings or plasma treatments. These materials prioritize biomimetic properties that mimic the natural tear film, achieving oxygen transmissibility (Dk/t) greater than 100 while maintaining a low modulus below 0.6 MPa for enhanced flexibility and lens handling. This generation addresses key comfort limitations from earlier silicone hydrogels, such as lipid deposition and dryness, through internal hydrophilic modifications that promote stable hydration throughout wear. Key examples of third-generation materials include comfilcon A, used in CooperVision's Biofinity line, with 48% water content, Dk/t of 116, and modulus of 0.5 MPa; samfilcon A, featured in Bausch + Lomb's Ultra lenses, offering 46% water content, Dk/t of 114, and modulus of 0.6 MPa; delefilcon A, employed in Alcon's Dailies Total1, which has a core water content of 33% increasing to 80% at the surface for a Dk/t of 156 and modulus of 0.5 MPa; and enfilcon A, introduced in 2011 for CooperVision's Avaira, with 46% water content and Dk/t of 103. These formulations emphasize a balance of high oxygen flow and low stiffness to support extended wear while minimizing mechanical irritation to the ocular surface.| Material | Brand Example | Water Content | Dk/t | Modulus (MPa) |
|---|---|---|---|---|
| Comfilcon A | Biofinity (CooperVision) | 48% | 116 | 0.5 |
| Samfilcon A | Ultra (Bausch + Lomb) | 46% | 114 | 0.6 |
| Delefilcon A | Dailies Total1 (Alcon) | 33% core / 80% surface | 156 | 0.5 |
| Enfilcon A | Avaira (CooperVision) | 46% | 103 | 0.5 |
