Method for making embedded hydrogel contact lenses

Abstract

A method for producing an embedded hydrogel contact lens, the method comprising at least the following steps: obtaining an insert made of a cross-linked polymer material, the cross-linked polymer material comprising an initiator-transfer terminator portion covalently attached thereto; placing the insert in a negative lens half-mold; adding an amount of lens forming composition to immerse the insert in the negative lens half-mold; tightly closing a positive lens half-mold onto the top of the negative lens half-mold to form a molding assembly; and curing the lens forming composition in the molding assembly to form an embedded hydrogel lens primer, the embedded hydrogel lens primer comprising a bulk hydrogel material formed of the lens forming composition and an insert embedded therein and covalently connected to the bulk hydrogel material.

Description

Technical Field

[0001] The present invention generally relates to a method for producing an embedded hydrogel contact lens. In addition, the present invention provides an embedded hydrogel contact lens produced according to the method of the present invention. Prior Art

[0002] Hydrogel contact lenses are widely used to correct many different types of vision impairments due to their comfortable, soft feel. They are made from a hydrated, cross-linked polymer material containing from about 20% to about 75% water by weight, balanced within the lens polymer matrix. Hydrogel contact lenses are typically produced using conventional full-cast molding methods. This conventional manufacturing process includes at least the following steps: lens molding (i.e., curing the polymerizable composition in the mold), demolding (i.e., removing the lens from the mold), extracting the lens with an extraction medium, hydrating the lens, packaging the hydrated lens, and sterilizing it. During hydration, hydrogel contact lenses absorb water and typically swell significantly in size.

[0003] In recent years, various inserts have been proposed for incorporation into hydrogel contact lenses for various purposes (e.g., for corneal health, vision correction, diagnosis, etc.). For example, see U.S. Patent Nos. 4,268,132, 4,401,371, 5,098,546, 5,156,726, 6,851,805, 7,104,648, 7,490,936, 7,883,207, 7,931,832, 8,154,804, 8,215,770, 8,348,424, 8,874,182, 8,922,898, 9,155,614, 9,1763 32, 9296158, 9618773, 9731437, 9889615, 9977260, 10203521, and 10209534; and U.S. patent application publication numbers 2004 / 0141150, 2009 / 0091818, 2010 / 0076553, 2011 / 0157544, and 2012 / 0140167.

[0004] Inserts are typically made of a non-hydrogel material that cannot absorb water and is non-water-swellable. A particular type of insert is a rigid insert made of a rigid material (i.e., a highly cross-linked polymer material) that acts as a rigid central optic for masking astigmatism, such as rigid gas permeable (RGP) contact lenses. For such inserts, significant differences in mechanical properties, particularly water swelling, are expected between the insert material and the silicone hydrogel lens material into which the insert is embedded. Due to these significant differences, embedded silicone hydrogel contact lenses are susceptible to lens deformation, particularly delamination, during hydration of the hydrogel contact lens into which the insert is embedded, as well as during handling and wear of the embedded silicone hydrogel contact lens. It would be desirable to have an embedded silicone hydrogel contact lens with a rigid, hydrophobic insert that is less prone to delamination.

[0005] U.S. Patent Application Publication No. 2018 / 0169905 A1 discloses an attempt to reduce deformation of an embedded contact lens comprising a hydrogel lens body and a non-swellable object embedded therein during hydration by selecting the surface energy of the non-swellable object and the modulus of the hydrogel lens body.

[0006] U.S. Patent No. 10,139,521 discloses a silicone elastomer-hydrogel hybrid contact lens comprising a silicone elastomer layer and a hydrogel layer adhered to the silicone elastomer layer by an anti-delamination bond formed by including an elastomer swellable monomer in a polymerizable composition used to form the hydrogel layer.

[0007] U.S. Patent Application Publication No. 2021 / 0292558 A1 discloses that when a polysiloxane vinyl crosslinker comprising hydrophilized siloxane units (each unit having a methyl substituent and an organic group including at least one H-bond donor) is added to a polymerizable composition during cast molding of embedded silicone hydrogel contact lenses (each contact lens having a rigid insert made of a hydrophobic cross-linked polymer material), the resulting embedded silicone hydrogel contact lenses are less susceptible to delamination. Summary of the Invention

[0008] In one aspect, the present invention provides a method for producing an embedded hydrogel contact lens, the method comprising the following steps: (1) obtaining an insert mold, wherein the insert mold comprises a male insert mold half having a first molding surface and a female insert mold half having a second molding surface, the male insert mold half and the female insert mold half being configured to receive each other such that when the female insert mold half is closed with the male insert mold half, an insert molding cavity is formed between the first molding surface and the second molding surface; (2) dispensing an insert forming composition into the female insert mold half, wherein the insert forming composition comprises (i) at least one polymerizable material, (ii) at least one first free radical initiator, and (iii) at least one iniferter; (3) closing the female insert mold half with the male insert mold half to form a first molded component, the first molded component comprising the insert forming composition within the insert molding cavity of the insert mold; and (4) thermally curing or photochemically curing the insert-forming composition in the insert-molding cavity of the first molding assembly to form a molded insert made of a first cross-linked polymer material comprising an iniferter moiety covalently attached thereto; (5) obtaining a lens mold and a lens-forming composition, wherein the lens mold comprises a male lens half-mold having a third molding surface and a female lens half-mold having a fourth molding surface, the male lens half-mold and the female lens half-mold being configured to receive one another such that when the female lens half-mold is closed to the male lens half-mold, a lens-molding cavity is formed between the third molding surface and the fourth molding surface, wherein the lens-forming composition comprises at least a second polymerizable material and a second free radical initiator; (6) in no particular order, placing the insert obtained in step (4) at a desired location in the female lens half-mold and dispensing the lens-forming composition in the female lens half-mold, wherein the insert is immersed in the lens-forming composition; (7) closing the female lens mold half with the male lens mold half to form a second molded component comprising the lens forming composition in the lens molding cavity of the lens mold and the insert immersed therein; (8) thermally or actinically curing the lens forming composition in the lens molding cavity of the second molded component while simultaneously initiating iniferter-induced polymerization of the lens forming composition at and near a surface of the insert to form an embedded hydrogel lens precursor comprising a bulk hydrogel material formed from the lens forming composition and the insert embedded in the bulk material, wherein the bulk hydrogel material is a second cross-linked polymeric material covalently linked to the first cross-linked polymeric material at iniferter moieties located at and near a surface of the insert;(9) separating the lens mold obtained in step (8) into the male lens mold half and the female lens mold half, wherein the embedded hydrogel lens precursor is adhered to the lens-adhered lens mold half, the lens-adhered lens mold half being one of the male lens mold half and the female lens mold half; (10) removing the embedded hydrogel lens precursor from the lens-adhered lens mold half (preferably before the embedded hydrogel lens precursor comes into contact with water or any liquid); and (11) subjecting the embedded hydrogel lens precursor to a post-molding process to form the embedded hydrogel contact lens, the process comprising a hydration process and one or more other processes selected from the group consisting of: extraction, surface treatment, packaging, sterilization, and combinations thereof.

[0009] In another aspect, the present invention provides an embedded hydrogel contact lens obtained according to the method of the present invention.

[0010] These and other aspects of the present invention will become apparent from the following description of the presently preferred embodiments. The detailed description is merely illustrative of the present invention and does not limit the scope of the invention, which is defined by the appended claims and their equivalents. As will be apparent to those skilled in the art, many variations and modifications of the present invention are possible without departing from the spirit and scope of the novel concepts disclosed herein. Simple diagram description

[0011] none Implementation Method

[0012] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In general, the nomenclature used herein and the laboratory procedures are those well known and commonly used in the art. Conventional methods were used for these procedures, as provided in the art and in various general references. When a term is provided in the singular, the inventors also contemplate the plural form of the term. The nomenclature used herein and the laboratory procedures described below are those well known and commonly used in the art.

[0013] In this application, "about" as used herein means that a number referred to as "about" includes the recited number plus or minus 1%-10% of that recited number.

[0014] "Contact lens" means a structure that is placed on or within the wearer's eye. Contact lenses can, but need not, correct, improve, or alter the wearer's vision. Contact lenses can be made of any suitable material known in the art or later developed and can be soft, hard, or inset.

[0015] A "hydrogel contact lens" is a contact lens comprising a hydrogel bulk (core) material. The hydrogel bulk material may be a non-silicone hydrogel material or, preferably, a silicone hydrogel material.

[0016] "Hydrogel" or "hydrogel material" refers to a cross-linked polymeric material having a three-dimensional polymer network (i.e., polymer matrix) that is insoluble in water but can hold at least 10% by weight of water in its polymer matrix when fully hydrated (or at equilibrium).

[0017] Siloxanes, also often described as silicones, are molecules having at least one -Si-O-Si- moiety, wherein each Si atom carries two organic groups as substituents.

[0018] "Silicone hydrogel" or "SiHy" refers to a silicone-containing hydrogel obtained by copolymerization of a polymerizable composition comprising at least one silicone-containing monomer, at least one silicone-containing macromer, or at least one cross-linkable silicone-containing prepolymer.

[0019] As used herein, the terms "non-silicone hydrogel" or "non-silicone hydrogel material" interchangeably refer to hydrogels that are theoretically free of silicone.

[0020] "Male mold half" or "bottom curved mold half" interchangeably refers to a mold half having (1) a molding surface that is substantially convex and defines the posterior (back) surface of a contact lens (or insert) and (2) a central axis that is a normal at the center of the molding surface.

[0021] "Female mold half" or "positive curvature mold half" interchangeably refers to a mold half having (1) a molding surface that is substantially concave and defines the front (front) surface of a contact lens (or insert) and (2) a central axis that is a normal at the center of the molding surface.

[0022] As used herein, the terms "front surface," "front face," "positively curved surface," or "FC surface" with respect to a contact lens or insert interchangeably refer to the surface of the contact lens or insert that faces away from the eye during wear. The front surface (front face) is typically substantially convex.

[0023] As used herein with respect to a contact lens or insert, "posterior surface," "back surface," "bottom curved surface," or "BC surface" interchangeably refers to the surface of the contact lens or insert that faces the eye during wear. The posterior surface (back surface) is typically substantially concave.

[0024] "Embedded hydrogel contact lens" refers to a hydrogel contact lens that includes at least one insert that is fully or partially embedded within the bulk hydrogel material of the embedded hydrogel contact lens.

[0025] As used herein, an "insert" refers to any preformed article having a diameter of up to 13 mm, a front (front) surface, an opposite back (posterior) surface, a central axis, and a thickness that is less than any thickness of the embedded hydrogel contact lens in the area in which the insert is embedded. It should be understood that the insert must be smaller than the dimensions of the embedded hydrogel contact lens in order to be embedded within the bulk material of the embedded hydrogel contact lens. The insert can be made of a polymeric material, which can be a non-hydrogel material or a hydrogel material. Examples of preferred inserts include, but are not limited to, thin, rigid inserts used to provide a rigid central optic for masking astigmatism, such as rigid gas permeable (RGP) contact lenses, multifocal lens inserts, photochromic inserts, cosmetic inserts with printed color patterns, and the like.

[0026] In this application, the central axis of an insert (or contact lens) refers to an imaginary line passing through the centers of both the front (front) surface and the back (back) surface of the insert (or contact lens).

[0027] According to the present invention, the non-hydrogel material can be any material that can absorb less than 5% (preferably about 4% or less, more preferably about 3% or less, even more preferably about 2% or less) by weight of water when fully hydrated.

[0028] As used herein, "hydrophilic" describes a material or portion thereof that will associate with water more readily than with lipids.

[0029] "Hydrophobic" means that the insert material or insert has an equilibrium water content (i.e., water content in a fully hydrated state) of less than 5%, preferably about 4% or less, more preferably about 3% or less, even more preferably about 2% or less.

[0030] The term "room temperature" refers to a temperature of about 22°C to about 26°C.

[0031] The term "soluble" with respect to a compound or material in a solvent means that the compound or material is soluble in the solvent at room temperature (i.e., a temperature of about 22°C to about 26°C) to give a solution having a concentration of at least about 0.5% by weight.

[0032] The term "insoluble" with respect to a compound or material in a solvent means that the compound or material is soluble in the solvent at room temperature (as defined above) to give a solution having a concentration of less than 0.01% by weight.

[0033] "Vinyl monomer" refers to a compound that has a single ethylenically unsaturated group, is soluble in a solvent, and can be photochemically or thermally polymerized.

[0034] "Polymerizable material" refers to a compound, a polymer (soluble in a solvent), or a mixture thereof that contains at least one ethylenically unsaturated group and can be polymerized actinically or thermally.

[0035] As used in this application, the term "ethylenically unsaturated group" is used in a broad sense herein and is intended to encompass any group containing at least one >C=CH2 group. Exemplary ethylenically unsaturated groups include, but are not limited to, (meth)acryloyl ( and / or ), vinyloxycarbonylamino ( , wherein R o is H or C 1-C 4 alkyl), vinyloxycarbonyloxy ( ), vinylaminocarbonylamino ( , wherein R o is H or C 1-C 4 alkyl), vinylaminocarbonyloxy ( ), allyl, vinyl, styryl ( or ), or other C=C-containing groups.

[0036] "Acrylic monomer" refers to a vinyl monomer having a single (meth)acryl group. Examples of acrylic monomers include (meth)acryloxy (or (meth)acryloyloxy) monomers and (meth)acrylamide monomers.

[0037] "(meth)acryloxy or (meth)acryloyloxy) monomer" means a monomer having a single or Group of vinyl monomers.

[0038] "(Meth)acrylamide monomer" or "(meth)acrylamide monomer" means a monomer having a single group or The vinyl monomer, wherein R o is H or C 1-C 4 alkyl.

[0039] The term "aryl acrylic monomer" refers to an acrylic monomer having at least one aromatic ring.

[0040] The term "(meth)acrylamide" refers to methacrylamide and / or acrylamide.

[0041] The term "(meth)acrylate" refers to methacrylate and / or acrylate.

[0042] "N-vinylamide monomer" refers to a monomer having a vinyl group directly attached to the nitrogen atom of the amide group ( ) of an amide compound.

[0043] "Ene monomer" refers to a vinyl monomer having a single olefinic group.

[0044] The term "ene group" refers to a monovalent group of CH2=CH- or CH2=CCH3- that is not covalently attached to an oxygen or nitrogen atom or a carbonyl group.

[0045] "Vinyloxycarbonyloxy monomer" refers to a vinylic monomer having a single vinyloxycarbonyloxy group.

[0046] "Vinyloxycarbonylamino monomer" refers to a vinyl monomer having a single vinyloxycarbonylamino group.

[0047] "Vinylaminocarbonyloxy monomer" refers to a vinyl monomer having a single vinylaminocarbonyloxy group.

[0048] "Vinylaminocarbonylamino monomer" refers to a vinyl monomer having a single vinylaminocarbonylamino group.

[0049] "Hydrophilic vinylic monomers" refer to vinylic monomers that typically yield homopolymers that are water-soluble or can absorb at least 10% by weight of water.

[0050] "Hydrophobic vinylic monomer" refers to a vinylic monomer that typically produces a homopolymer that is insoluble in water and can absorb less than 10% by weight of water.

[0051] As used herein, the term "ethylenic crosslinking agent" refers to an organic compound having at least two ethylenically unsaturated groups. "Ethylenic crosslinking agent" refers to an ethylenic crosslinking agent having a molecular weight of 700 Daltons or less.

[0052] The term "acrylic crosslinking agent" refers to a vinyl crosslinking agent having at least two (meth)acryloyl groups.

[0053] The term "acrylic repeating units" refers to repeating units of a polymeric material that are each derived from an acrylic monomer or a crosslinker that is free radically polymerized to form the polymeric material.

[0054] The term "terminal (meth)acryl group" refers to a (meth)acryl group at one of the two ends of the main chain (or backbone) of an organic compound, as known to those skilled in the art.

[0055] As used herein, "actinically" with respect to curing, crosslinking, or polymerizing a polymerizable composition, prepolymer, or material means curing (e.g., crosslinking and / or polymerizing) by actinic irradiation, such as, for example, UV / visible light irradiation, ionizing radiation (e.g., gamma ray or X-ray irradiation), microwave irradiation, etc. Thermal curing or photochemical curing methods are well known to those skilled in the art.

[0056] As used in this application, the term "polymer" means a material formed by polymerizing / crosslinking one or more monomers or macromers or prepolymers or a combination thereof.

[0057] "Macromer" or "prepolymer" refers to a compound or polymer containing ethylenically unsaturated groups and having a number average molecular weight greater than 700 Daltons.

[0058] As used herein, the term "molecular weight" of a polymeric material (including monomeric or macromer materials) refers to the mesh average molecular weight, unless specifically stated otherwise or unless testing conditions indicate otherwise. A skilled artisan knows how to determine the molecular weight of a polymer according to known methods, such as GPC (gel permeation chromatography) with one or more of the following: a refractive index detector, a low-angle laser light scattering detector, a multi-angle laser light scattering detector, a differential viscometry detector, a UV detector, and an infrared (IR) detector; MALDI-TOF MS (matrix-assisted laser desorption / ionization time-of-flight mass spectrometry); 1H NMR (proton nuclear magnetic resonance) spectroscopy, and the like.

[0059] "Polysiloxane segment" or "polydiorganosiloxane segment" refers interchangeably to polymer chain segments. (i.e., a divalent group), wherein SN is an integer of 3 or greater and each of R S1 and R S2 is independently selected from the group consisting of: C 1-C 10 alkyl; phenyl; C 1-C 4-alkyl-substituted phenyl; C 1-C 4-alkoxy-substituted phenyl; phenyl-C 1-C 6-alkyl; C 1-C 10 fluoroalkyl; C 1-C 10 fluoroether; aryl; aryl C 1-C 18 alkyl; -alk-(OC 2H 4) γ1-OR o (wherein alk is a C 1-C 6 alkylene diyl, R o is H or C 1-C 4 alkyl and γ1 is an integer from 1 to 10); a C 2-C 40 organic group having at least one group selected from the group consisting of a hydroxyl group (—OH), a carboxyl group (—COOH), an amine group (—NR N1R N1′), an amine linker -NR N1-, an amide linker -CONR A functional group selected from the group consisting of R N1-, amide -CONR N1R N1', a urethane linker -OCONH-, and a C 1-C 4 alkoxy group, or a linear hydrophilic polymer chain, wherein R N1 and R N1' are independently hydrogen or a C 1-C 15 alkyl group; and a photochromic organic group having a photochromic group.

[0060] "Polysiloxane vinyl monomer" or "polysiloxane vinyl monomer" interchangeably refers to a compound containing at least one polysiloxane segment and a single ethylenically unsaturated group.

[0061] "Polydiorganosiloxane vinyl crosslinker" or "polysiloxane vinyl crosslinker" interchangeably refers to a compound comprising at least one polysiloxane segment and at least two ethylenically unsaturated groups.

[0062] "Linear polydiorganosiloxane vinyl crosslinker" or "linear polysiloxane vinyl crosslinker" interchangeably refers to a compound comprising a backbone comprising at least one polysiloxane segment and terminated at each of the two ends of the backbone with an ethylenically unsaturated group.

[0063] "Chain-extended polydiorganosiloxane vinyl crosslinker" or "chain-extended polysiloxane vinyl crosslinker" interchangeably refers to a compound comprising at least two ethylenically unsaturated groups and at least two polysiloxane segments, each pair of polysiloxane segments being linked by a divalent group.

[0064] As used herein, the term "fluid" indicates a material capable of flowing like a liquid.

[0065] As used herein, with respect to a polymerizable composition, the term "transparent" means that the polymerizable composition is a transparent solution or liquid mixture (i.e., having a light transmittance of 85% or greater, preferably 90% or greater, in the range between 400 and 700 nm).

[0066] The term "monovalent group" refers to an organic group obtained by removing a hydrogen atom from an organic compound and forming a bond with another group in the organic compound. Examples include, but are not limited to, alkyl (formed by removing a hydrogen atom from an alkane), alkoxy (or alkoxyl) (formed by removing a hydrogen atom from the hydroxyl group of an alkyl alcohol), thiyl (formed by removing a hydrogen atom from the mercapto group of an alkylthiol), cycloalkyl (formed by removing a hydrogen atom from a cycloalkane), cycloheteroalkyl (formed by removing a hydrogen atom from a cycloheteroalkane), aryl (formed by removing a hydrogen atom from the aromatic ring of an aromatic hydrocarbon), heteroaryl (formed by removing a hydrogen atom from any ring atom), amine (formed by removing a hydrogen atom from an amine), and the like.

[0067] The term "divalent group" refers to an organic group derived by removing two hydrogen atoms from an organic compound and forming two bonds with two other groups in the organic compound. For example, an alkylene (i.e., alkylenyl) divalent group is derived by removing two hydrogen atoms from an alkane, and a cycloalkylene (i.e., cycloalkylenyl) divalent group is derived by removing two hydrogen atoms from a ring.

[0068] In the present application, the term "substituted" with respect to an alkyl group or an alkylene group means that the alkyl group or the alkylene group includes at least one substituent, which replaces one hydrogen atom of the alkyl group or the alkylene group and is selected from the group consisting of hydroxyl (-OH), carboxyl (-COOH), -NH2, mercapto (-SH), C1-C4 alkyl, C1-C4 alkoxy, C1-C4 alkylthio (alkyl sulfide), C1-C4 acylamino, C1-C4 alkylamino, di-C1-C4 alkylamino, and combinations thereof.

[0069] Free radical initiators can be photoinitiators or thermal initiators. A "photoinitiator" refers to a chemical that initiates a free radical crosslinking / polymerization reaction by utilizing light. A "thermal initiator" refers to a chemical that initiates a free radical crosslinking / polymerization reaction by utilizing heat energy.

[0070] The "oxygen permeability" Dk of a material is the rate at which oxygen passes through the material and can be measured at about 34°C-35°C according to the procedure described in Example 1. Oxygen permeability is conventionally expressed in barrers, where a "barrer" is defined as [(cm3 oxygen)(mm) / (cm2)(sec)(mm Hg)] x 10-10.

[0071] The "oxygen transmission rate" (Dk / t) of an insert or material is the rate at which oxygen will pass through a particular insert or material having an average thickness t (in mm) over the measured area. Oxygen transmission rate is conventionally expressed in units of barrers / mm, where "barrers / mm" is defined as [(cm3 oxygen) / (cm2)(sec)(mm Hg)] x 10-9.

[0072] The term "modulus" or "elastic modulus" with respect to a contact lens or material means the tensile modulus or Young's modulus as a measure of the stiffness of the contact lens or material. The modulus can be measured according to the procedure described in Example 1.

[0073] An "iniferter" refers to a compound that acts simultaneously as an initiator, transfer agent, and terminator in free radical polymerization. Following polymerization, the iniferter is incorporated into the resulting polymer as a terminal group on the polymer chain. It should be understood that, as is known to those skilled in the art, free radical initiators can be used to initiate iniferter-induced polymerization.

[0074] "Iniferter moiety" refers to a monovalent group obtained by removing a hydrogen atom from an iniferter.

[0075] Generally, the present invention relates to a method for producing embedded hydrogel contact lenses, each of which comprises a bulk hydrogel material and an insert embedded within the bulk hydrogel material and formed from a cross-linked polymeric material covalently attached to the bulk hydrogel material. The invention is based, in part, on the discovery that inserts formed from a cross-linked polymeric material comprising iniferter moieties covalently attached thereto can be prepared by curing an insert-forming composition comprising a free radical initiator and an iniferter. In the absence or, preferably, in the presence of a free radical initiator, the iniferter moieties can be used to induce graft polymerization of a polymerizable material in the lens-forming composition with the polymer matrix of the insert at and near its surface. Such preformed inserts can be reactive in the presence of free radicals. When used to cast-mold an embedded hydrogel contact lens from a lens-forming composition comprising a free radical initiator, the bulk hydrogel material formed from the lens-forming composition becomes covalently attached to the iniferter moieties of the insert at and near the surface of the insert. Due to the covalent bonds between the bulk hydrogel material and the insert embedded therein, the resulting embedded hydrogel contact lens can have minimized susceptibility to delamination.

[0076] In one aspect, the present invention provides a method for producing an embedded hydrogel contact lens, the method comprising the following steps: (1) obtaining an insert mold, wherein the insert mold comprises a male insert mold half having a first molding surface and a female insert mold half having a second molding surface, the male insert mold half and the female insert mold half being configured to receive each other such that when the female insert mold half is closed with the male insert mold half, an insert molding cavity is formed between the first molding surface and the second molding surface; (2) dispensing an insert forming composition into the female insert mold half, wherein the insert forming composition comprises (i) at least one polymerizable material, (ii) at least one first free radical initiator, and (iii) at least one iniferter; (3) closing the female insert mold half with the male insert mold half to form a first molded component, the first molded component comprising the insert forming composition within the insert molding cavity of the insert mold; and (4) thermally curing or photochemically curing the insert-forming composition in the insert-molding cavity of the first molding assembly to form a molded insert made of a first cross-linked polymer material comprising an iniferter moiety covalently attached thereto; (5) obtaining a lens mold and a lens-forming composition, wherein the lens mold comprises a male lens half-mold having a third molding surface and a female lens half-mold having a fourth molding surface, the male lens half-mold and the female lens half-mold being configured to receive one another such that when the female lens half-mold is closed to the male lens half-mold, a lens-molding cavity is formed between the third molding surface and the fourth molding surface, wherein the lens-forming composition comprises at least a second polymerizable material and a second free radical initiator; (6) in no particular order, placing the insert obtained in step (4) at a desired location in the female lens half-mold and dispensing the lens-forming composition in the female lens half-mold, wherein the insert is immersed in the lens-forming composition; (7) closing the female lens mold half with the male lens mold half to form a second molded component comprising the lens forming composition in the lens molding cavity of the lens mold and the insert immersed therein; (8) thermally or actinically curing the lens forming composition in the lens molding cavity of the second molded component while simultaneously initiating iniferter-induced polymerization of the lens forming composition at and near a surface of the insert to form an embedded hydrogel lens precursor comprising a bulk hydrogel material formed from the lens forming composition and the insert embedded in the bulk material, wherein the bulk hydrogel material is a second cross-linked polymeric material covalently linked to the first cross-linked polymeric material at iniferter moieties located at and near a surface of the insert;(9) separating the lens mold obtained in step (8) into the male lens mold half and the female lens mold half, wherein the embedded hydrogel lens precursor is adhered to the lens-adhered lens mold half, the lens-adhered lens mold half being one of the male lens mold half and the female lens mold half; (10) removing the embedded hydrogel lens precursor from the lens-adhered lens mold half (preferably before the embedded hydrogel lens precursor comes into contact with water or any liquid); and (11) subjecting the embedded hydrogel lens precursor to a post-molding process to form the embedded hydrogel contact lens, the process comprising a hydration process and one or more other processes selected from the group consisting of: extraction, surface treatment, packaging, sterilization, and combinations thereof.

[0077] Mold halves for manufacturing contact lenses (or inserts) are well known to those skilled in the art and are used, for example, in cast molding. Typically, a molding assembly comprises at least two mold halves, a male mold half and a female mold half. The male mold half has a molding (or optical) surface that directly contacts a polymerizable composition used to cast-mold a contact lens (or insert) and defines the posterior (back) surface of the molded contact lens (or molded insert); and the female mold half has a molding (or optical) surface that directly contacts the polymerizable composition and defines the anterior (front) surface of the molded contact lens (or molded insert). The male and female mold halves are configured to receive one another so that a lens-forming cavity or an insert-forming cavity is formed between the first and second molding surfaces.

[0078] Methods for making mold halves for cast-molding contact lenses or inserts are generally well known to those skilled in the art. The inventive method is not limited to any particular method for forming a mold half. In fact, any method for forming a mold half may be used in the present invention. The mold halves can be formed by various techniques, such as injection molding or lathing. Examples of suitable methods for forming mold halves are disclosed in U.S. Patent Nos. 4,444,711; 4,460,534; 5,843,346; and 5,894,002.

[0079] Almost any material known in the art for making mold halves can be used to make mold halves for producing contact lenses or inserts. For example, polymeric materials such as polyethylene, polypropylene, polystyrene, PMMA, Topas® COC grade 8007-S10 (a clear, amorphous copolymer of ethylene and norbornene available from Ticona GmbH, Frankfurt, Germany and Summit, New Jersey, USA), and the like can be used.

[0080] According to the present invention, the insert-forming composition is a polymerizable composition, which can be any polymerizable composition used to form plastic materials, as long as it contains an iniferter and a free radical initiator (thermal initiator or photoinitiator).

[0081] Any iniferter may be used in the present invention. A variety of iniferters have been disclosed in patents and scientific publications and can be obtained from commercial suppliers or prepared according to the procedures described in patents (e.g., US 4581429, US 5240972, US 5449703, US 5658986, US 5866047, US 6255422, US 6833276, US 7351781, EP 507036, EP 418118, EP 342073, EP 338918, WO 98 / 30601, WO 96 / 24620, and WO 99 / 03894) or publications (e.g., Chen et al., Chem. Rev. 2016, 116: 10167-10211; Takayuki Otsu, J. Polym. Sci.: Part A: Polym. Chem. [Journal of Polymer Science, Part A: Polymer Chemistry] 2000, 38: 2121-2136). Preferably, the iniferter is a thiocarbonylthio-containing compound (i.e., having a thiocarbonylthio moiety). ) or organic nitrogen oxide compounds (i.e., having a nitrogen oxide moiety ).

[0082] Thiocarbonylthio compounds are well known to those skilled in the art. Examples of thiocarbonylthio compounds include, but are not limited to, dithioesters, dithiocarbamates, dithioesters, trithiocarbonates, xanthates, thiuram disulfides, and xanthate disulfides.

[0083] Examples of preferred thiocarbonylthio-containing compounds include, but are not limited to, thiuram monosulfide, N,N'-dimethylthiuram monosulfide, N,N,N',N'-tetramethylthiuram monosulfide, N,N'-diethylthiuram monosulfide, N,N,N',N'-tetraethylthiuram monosulfide, thiuram disulfide, N,N-dimethylthiuram disulfide, N,N'-diethylthiuram disulfide, N,N'-diethyl-N,N'-bis(2-hydroxyethyl)thiuram disulfide, N,N'-bis(N-(2-phthalimidoethyl)piperidinium-thiuram disulfide), N,N'-dimethylthiuram tetrasulfide, tetramethylthiuram disulfide, tetraethylthiuram disulfide, tetraisopropylthiuram disulfide, N,N'-dimethyl N,N'-di(4-pyridyl)thiuram disulfide, bis(thiobenzoyl) disulfide, diisopropyl xanthate disulfide, dithiobenzoic acid cyanomethyl ester, dithiobenzoic acid benzyl ester, dithiobenzoic acid 2-phenyl-2-propyl ester, bis(thiobenzoyl) disulfide, 1 Benzyl H-pyrrole-1-dithiocarboxylate, 2-cyano-2-propyl dithiobenzoate, bis(carboxymethyl)trithiocarbonate, 4-cyano-4-(thiobenzoylthio)pentanoic acid, ethyl 2-(phenylthiocarbonylthio)-2-phenylacetate, ethyl 2-(phenylthiocarbonylthio)-propionate, 1-(methoxycarbonyl)ethyl dithiobenzoate, 2-cyano-2-propyl 4-cyanodithiobenzoate, 2-(4-methoxy ethyl 2-(phenylthiocarbonylthio)propionate, ethyl 2-(phenylthiocarbonylthio)-2-phenylacetate, 2-(4-methoxyphenylthiocarbonylthio)acetic acid, 2-nitro-5-(2-propynyloxy)benzyl 4-cyano-4-(phenylthiocarbonylthio)pentanoate, S,S-bis(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, S-dodecyl-S′ -(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, S-ethyl-S′-(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, 4-cyano-4-ethyl-trithiopentanoic acid, S,S-dibenzyl trithiocarbonate, bis(carboxymethyl) trithiocarbonate, dimethyl trithiocarbonate, o-phthalimidomethylbutyl trithiocarbonate, cyanomethyldodecyl trithiocarbonate, 4-cyano-4-[( dodecylthiothiocarbonyl)thio]pentanoic acid, 3,5-bis(2-dodecylthiothiocarbonylthio-1-oxopropyloxy)benzoic acid, 2-(2-carboxyethylthiothiocarbonylthio)-propionic acid, 2-cyano-2-propyldodecyl trithiocarbonate, 2-(dodecylthiothiocarbonylthio)-2-methylpropionic acid 3-butenyl ester, 2-(dodecylthiothiocarbonylthio)-2-methylpropionic acid, (3,5-dimethyl-1H-pyrazole)-dithiocarbamate, 2-cyanobutyl-2-yl 4-chloro-3,5-dimethyl-1H-pyrazole-1-dithiocarbamate, 2-[methyl(4-pyridyl)thiocarbamate-1H-pyrazole-1-dithiocarbamate]methyl ester, 2-cyanobutyl-2-yl 3,5-dimethyl-1H-pyrazole-1-dithiocarbamate, cyanomethylmethyl(phenyl)dithiocarbamate, cyanomethylmethyl(4-pyridyl)dithiocarbamate, 1 Benzyl H-pyrrole-1-dithiocarbamate, cyanomethyldiphenyldithiocarbamate, cyanomethylmethyl (4-pyridyl)dithiocarbamate, benzyl-N,N-dimethyldithiocarbamate, benzyl-N,N-diethyldithiocarbamate, 2-(N,N-diethyldithiocarbamate)isobutyric acid, ethyl 2-(N,N-diethyldithiocarbamate)isobutyrate, (4-cyano-4- diethyldithiocarbamoyl) valeric acid, 1-(ethoxycarbonyl)propan-1-yl dithiobenzoate, benzoylmethyl iodine-4-dithiocarbamoyl, S-2-cyano-2-propyl-O-ethyl xanthate, 1-phenylethylphenyl dithioacetate, S-methacryloyl O-ethyl xanthate, 2-(N,N-diethyldithiocarbamoyl)ethyl methacrylate, 2-(N,N-diethyldithiocarbamoyl)ethyl methacrylate, 2-(N,N-dimethylamino)propanedithiocarbamate ... ethyl dithiocarbamate) ethyl ether, dithiobenzocyanovalerate, 3-benzylthiocarbonylthiohydrogenthiopropionic acid, 2-(n-butyl trithiocarbonate)-propionic acid, n-butyl N,N-dimethyldithiocarbamate, benzyl dithiocarbamate, p-xylene-bis(dithiocarbamate), p-xylene-bis(N,N-dimethyldithiocarbamate), p-xylene-bis(N,N-diethyldithiocarbamate), thiocarbamate), 1,2-bis(N,N-diethyldithiocarbamate)ethane, 1,2-bis(N,N-dimethyldithiocarbamate)ethane, 1,2,3-tris(N,N-dimethyldithiocarbamate)propane, 1,2,4,5-tetrakis(N,N-diethyldithiocarbamatemethyl)benzene, 1-(N,N-diethyldithiocarbamate)ethyl acetate, and combinations thereof.

[0084] Examples of preferred organic nitrogen oxide compounds include, but are not limited to, ((2',2',6',6'-tetramethyl-1'-piperidinyloxy)methyl)benzene, 1-phenyl-1-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)ethane, 1-(4'-bromophenyl)-1-(2",2",6",6"-tetramethyl-1"-piperidinyloxy)ethane, 1-naphthyl-1-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)-ethane, 1-phenyl-1-(2',2',6',6'-tetramethyl- 1-piperidinyloxy)propane, 1-(benzyloxy)-2-phenyl-2-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)ethane, 1-hydroxy-2-phenyl-2-(2',2',6',6'-tetramethyl-1-piperidinyloxy)ethane, 4-cyano-4-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)phenyl pentanoate, 4-cyano-4-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)pentanoic acid pentafluorophenyl ester, 3-phenyl-1-(2',2',6' ,6'-tetramethyl-1'-piperidinyloxy)propane, 1-((2',2',6',6'-tetramethyl-1'-piperidinyloxy)methyl)-4-(trifluoromethyl)benzene, 2-((4-benzoylphenyl)((1-methoxy-2-methyl-1-oxopropyl-2-yl)oxy)amino)-2-methylpropionic acid methyl ester, 2,2,6,6-tetramethyl-1-piperidinyloxy, 2,2,5-trimethyl-4-phenyl-3-azahexane-3-nitrogen oxide, N-tertiary butyl-N-1-phenyl-2-methylpropyl-nitrogen oxide, N -tert-butyl-N-1-(2-naphthyl)-2-methylpropyl nitroxide, N-tert-butyl-N-1-diethylphosphonyl-2,2-dimethylpropyl nitroxide, N-tert-butyl-N-1-dibenzylphosphonyl-2,2-dimethylpropyl nitroxide, N-phenyl-N-1-diethylphosphonyl-2,2-dimethylpropyl nitroxide, N-phenyl-N-1-diethylphosphonyl-1-methylethyl nitroxide, N-(1-phenyl-2-methylpropyl)-N-1-diethyl-phosphonyl-1-methylethyl nitroxide, and combinations thereof.

[0085] According to the present invention, any thermal free radical initiator can be used in the insert-forming composition of the present invention. Suitable thermal free radical initiators are known to those skilled in the art and include, for example, peroxides, hydroperoxides, azo-bis(alkyl- or cycloalkylnitriles), persulfates, percarbonates, or mixtures thereof. Examples of preferred thermal free radical initiators include, but are not limited to, benzoyl peroxide, tert-butyl peroxide, tert-amyl peroxybenzoate, 2,2-bis(tert-butylperoxy)butane, 1,1-bis(tert-butylperoxy)cyclohexane, 2,5-bis(tert-butylperoxy)-2,5-dimethylhexane, 2,5-bis(tert-butylperoxy)-2,5-dimethyl-3-hexyne, bis(1-(tert-butylperoxy)-1-methyl 1,1-Bis(tertiary butylperoxy)-3,3,5-trimethylcyclohexane, di-tertiary butyl-diperoxyphthalate, tertiary butyl hydroperoxide, tertiary butyl peracetate, tertiary butyl peroxybenzoate, tertiary butyl peroxyisopropyl carbonate, acetyl peroxide, lauryl peroxide, decyl peroxide, dicetyl peroxydicarbonate, di(4-tertiary butylcyclohexyl) peroxydicarbonate (Perkadox 16S), di(2-ethylhexyl) peroxydicarbonate, tertiary butyl peroxy pivalate (Lupersol 11); tertiary butyl peroxy-2-ethylhexanoate (Trigonox 21-C50), 2,4-pentanedione peroxide, diisopropylphenyl peroxide, peracetic acid, potassium persulfate, sodium persulfate, ammonium persulfate, 2,2′-azobis(4-methoxy-2,4-dimethylvaleronitrile) (VAZO 33), 2,2′-azobis[2-(2-imidazolin-2-yl)propane] dihydrochloride (VAZO 44), 2,2′-azobis(2-amidinopropane) dihydrochloride (VAZO 50), 2,2′-azobis(2,4-dimethylvaleronitrile) (VAZO 52), 2,2′-azobis(isobutyronitrile) (VAZO 64 or AIBN), 2,2'-azobis-2-methylbutyronitrile (VAZO 67), 1,1-azobis(1-cyclohexanecarbonitrile) (VAZO 88); 2,2'-azobis(2-cyclopropylpropionitrile), 2,2'-azobis(methyl isobutyrate), 4,4'-azobis(4-cyanovaleric acid), and combinations thereof. Preferably, the thermal initiator is 2,2'-azobis(isobutyronitrile) (AIBN or VAZO 64).

[0086] According to the present invention, any free radical photoinitiator known to those skilled in the art can be used in the insert-forming composition of the present invention. Suitable photoinitiators are benzophenone derivatives, α-hydroxyketones, α-aminoketones, acylphosphine oxide derivatives, and acylgermanium derivatives. Examples of preferred photoinitiators include, but are not limited to, benzoin methyl ether, diethoxyacetophenone, benzoylphosphine oxide, 1-hydroxycyclohexylphenyl ketone, and the Darocur and Irgacur types, preferably Darocur 1173® and Darocur 2959®, and the germanium-based Norrish Type I photoinitiators (such as those described in US Pat. No. 7,605,190). Examples of benzylphosphine initiators include 2,4,6-trimethylbenzyldiphenylphosphine oxide; bis-(2,6-dichlorobenzyl)-4-N-propylphenylphosphine oxide; and bis-(2,6-dichlorobenzyl)-4-N-butylphenylphosphine oxide. Reactive photoinitiators, such as those that can be incorporated into macromonomers or used as special monomers, are also suitable. Examples of reactive photoinitiators are those disclosed in EP 632329.

[0087] According to the present invention, the insert-forming composition (i.e., polymerizable composition) must contain at least one polymerizable material in addition to the free radical initiator and the iniferter. The polymerizable material may include one or more vinyl monomers and one or more vinyl crosslinking agents known to those skilled in the art.

[0088] In a preferred embodiment, the insert-forming composition is a polymerizable composition for forming a hard plastic, such as any known to those skilled in the art, preferably cross-linked polymethyl methacrylate or polystyrene.

[0089] In another preferred embodiment, the insert-forming composition is used to form a cross-linked silicone polymer (or silicone rubber or elastomer as known to those skilled in the art), such as any polymerizable composition known to those skilled in the art. The cross-linked silicone material has a three-dimensional polymer network (i.e., a polymer matrix), is insoluble in water, and has an equilibrium water content (i.e., in a fully hydrated state) of about 5% by weight or less, preferably about 3% by weight or less, and more preferably about 2% by weight or less.

[0090] In another preferred embodiment, the insert-forming composition is a polymerizable composition for forming a non-silicone hydrogel material (any of those described later in this application or any known to those skilled in the art).

[0091] In another preferred embodiment, the insert-forming composition is a polymerizable composition for forming a silicone hydrogel material (any of those described later in this application or any known to those skilled in the art).

[0092] In another preferred embodiment, the insert-forming composition is a polymerizable composition for forming a rigid, breathable material (e.g., a material made of fluorosilicone acrylate or other materials known to those skilled in the art).

[0093] In another preferred embodiment, the insert-forming composition comprises at least one polymerizable photochromic compound (i.e., at least one photochromic vinylic monomer), at least one UV-absorbing vinylic monomer, at least one UV / HEVL-absorbing vinylic monomer, a fluorescent vinylic monomer, or a combination thereof.

[0094] In another preferred embodiment, the insert-forming composition comprises at least one photochromic dye or pigment, at least one color filter material for correcting color blindness, a diffractive material, a high refractive index material, or a combination.

[0095] In another preferred embodiment, the insert-forming composition is a polymerizable composition for forming a hydrophobic cross-linked acrylic material having an equilibrium water content of less than 5% by weight and comprising at least about 55% by mole (preferably at least about 60%, more preferably at least about 65%, even more preferably at least about 70%) of one or more acrylic monomers and / or one or more acrylic crosslinkers or crosslinking agents and at least about 6% by mole (preferably at least about 8% by mole, more preferably at least about 10% by mole, even more preferably at least about 12% by mole) of at least one vinyl crosslinking agent.

[0096] Any hydrophobic acrylic monomer can be used to form the hydrophobic cross-linked acrylic material of the present invention. Examples of hydrophobic acrylic monomers include silicone-containing acrylic monomers (any of those described below in this application), non-silicone hydrophobic acrylic monomers (any of those described below in this application), fluorine-containing acrylic monomers (any of those described below in this application), aromatic acrylic monomers (any of those described below in this application), and combinations thereof.

[0097] It should also be understood that any hydrophobic vinyl monomer can be used as a substitute for the hydrophobic acrylic monomer, as long as it includes at least one H-bond acceptor, such as an ester bond, an amide bond, a carbonate bond, a urethane bond, an ether bond, or a combination thereof. Examples of such hydrophobic monomers include vinyl alkanoates (any of those described above in this application), vinyloxyalkanes (any of those described above in this application), and combinations thereof.

[0098] According to the present invention, the insert-forming composition includes at least one vinyl crosslinker. Any suitable vinyl crosslinker can be used in the present invention. Preferred examples of vinyl crosslinkers include, but are not limited to, acrylic crosslinkers (any of those described later in this application), allyl methacrylate, allyl acrylate, aromatic crosslinkers (e.g., divinylbenzene, 2-methyl-1,4-divinylbenzene, bis(4-vinylphenyl)methane, 1,2-bis(4-vinylphenyl)ethane, etc.), triallyl isocyanurate, 2,4,6-triallyloxy-1,3,5-trisinium, 1,2,4-trivinylcyclohexane, or combinations thereof. It will be appreciated that a vinyl crosslinker is required to impart the desired rigidity to the crosslinked polymer material of the rigid hydrophobic insert.

[0099] In a preferred embodiment, the insert-forming composition comprises at least one acrylic crosslinker (any of those described later in this application).

[0100] In another preferred embodiment, the insert-forming composition comprises at least one aromatic cross-linking agent (any of those described later in this application).

[0101] In another preferred embodiment, the insert-forming composition comprises at least one vinyl-functional polysiloxane comprising at least two vinyl groups, each directly attached to a silicon atom, and at least 15% by mole of siloxane units, each having at least one phenyl substituent.

[0102] Examples of such vinyl-functional polysiloxanes include, but are not limited to, vinyl-terminated polyphenylmethylsiloxane (e.g., PMV9925 from Gelest), vinylphenylmethyl-terminated phenylmethyl-vinylphenylsiloxane copolymer (e.g., PVV-3522 from Gelest), vinyl-terminated diphenylsiloxane-dimethylsiloxane copolymer (e.g., PDV-1625 from Gelest), or combinations thereof. Preferably, the vinyl-functional polysiloxane is vinyl-terminated polyphenylmethylsiloxane (e.g., PMV9925 from Gelest), vinylphenylmethyl-terminated phenylmethyl-vinylphenylsiloxane copolymer (e.g., PVV-3522 from Gelest), or combinations thereof.

[0103] The insert-forming composition can be prepared by mixing all the polymerizable materials described above in the desired proportions together with one or more free radical initiators and iniferters in the presence or absence of a non-reactive organic solvent (ie, non-reactive diluent) described later in this application.

[0104] Lens-forming compositions (also known as polymerizable compositions) are described in numerous patents and are well known to those skilled in the art. There are generally two types of lens-forming compositions: those used to form non-silicone hydrogel contact lenses (i.e., the non-silicone hydrogel bulk materials herein) and those used to form silicone hydrogel contact lenses (i.e., the silicone hydrogel bulk materials herein).

[0105] Typically, the lens forming composition for forming the non-silicone hydrogel bulk material is (1) a monomer mixture comprising (a) at least one hydrophilic vinylic monomer (e.g., a hydroxyl-containing vinylic monomer, an N-vinylamide monomer, a (meth)acrylamide monomer, or a combination thereof), (b) a vinylic crosslinker, and (c) at least one component selected from the group consisting of a hydrophobic vinylic monomer, a free radical initiator (a photoinitiator or a thermal initiator), a UV-absorbing vinylic monomer, a high energy ultraviolet light ("HEVL") absorbing vinylic monomer, a visibility tint, and combinations thereof; or (2) An aqueous solution comprising one or more water-soluble prepolymers and at least one component selected from the group consisting of a hydrophilic vinylic monomer, a vinylic crosslinking agent, a hydrophobic vinylic monomer, a lubricant (or so-called internal wetting agent incorporated into the lens formulation), a free radical initiator (photoinitiator or thermal initiator), a UV-absorbing vinylic monomer, a HEVL-absorbing vinylic monomer, a visibility tint, and combinations thereof.

[0106] Examples of water-soluble prepolymers include, but are not limited to, water-soluble cross-linked poly(vinyl alcohol) prepolymers described in U.S. Pat. Nos. 5,583,163 and 6,303,687; water-soluble vinyl-terminated polyurethane prepolymers described in U.S. Pat. No. 6,995,192; derivatives of polyvinyl alcohol, polyethyleneimine, or polyvinylamine disclosed in U.S. Pat. No. 5,849,841; water-soluble cross-linkable polyurea prepolymers described in U.S. Pat. Nos. 6,479,587 and 7,977,430; cross-linkable polyacrylamide; vinyl lactam disclosed in U.S. Pat. No. 5,712,356. crosslinkable statistical copolymers of MMA and comonomers; crosslinkable copolymers of vinyl lactam, vinyl acetate and vinyl alcohol disclosed in U.S. Patent No. 5,665,840; polyether-polyester copolymers with crosslinkable side chains disclosed in U.S. Patent No. 6,492,478; branched polyalkylene glycol-urethane prepolymers disclosed in U.S. Patent No. 6,165,408; polyalkylene glycol-tetra(meth)acrylate prepolymers disclosed in U.S. Patent No. 6,221,303; and crosslinkable polyallylamine gluconolactone prepolymers disclosed in U.S. Patent No. 6,472,489.

[0107] A variety of lens-forming compositions for forming non-silicone hydrogel bulk materials (contact lenses) have been described in numerous patents and patent applications published as of the filing date of this application and have been used to produce commercial non-silicone hydrogel contact lenses. Examples of commercial non-silicone hydrogel contact lenses include, but are not limited to, alfafilcon A, acofilcon A, deltafilcon A, etafilcon A, focofilcon A, helfilcon A, helfilcon B, hilafilcon B, hioxifilcon A, hioxifilcon B, hioxifilcon D, methafilcon A, methafilcon B, nelfilcon A, nesofilcon A, ocufilcon A, ocufilcon B, ocufilcon C, ocufilcon D, omafilcon A, phemfilcon A, polymacon, samfilcon A, telfilcon A, tetrafilcon A, and vifilcon A. These can be used as lens-forming compositions in the present invention.

[0108] Preferably, the lens-forming composition for forming the non-silicone hydrogel bulk material comprises at least 50% by mole of at least one hydroxyl-containing vinyl monomer, preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, N-2-hydroxyethyl (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris (hydroxymethyl)methyl (meth)acrylamide, vinyl alcohol, allyl alcohol, and combinations thereof, more preferably selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, hydroxyethyl (meth)acrylamide, and vinyl alcohol.

[0109] A variety of lens-forming compositions for forming silicone hydrogel contact lenses (bulk materials) have been described in numerous patents and patent applications published as of the filing date of this application and have been used to produce commercial SiHy contact lenses. Examples of commercial SiHy contact lenses include, but are not limited to, asmofilcon A, balafilcon A, comfilcon A, delefilcon A, efrofilcon A, enfilcon A, fanfilcon A, galyfilcon A, lotrafilcon A, lotrafilcon B, narafilcon A, narafilcon B, senofilcon A, senofilcon B, senofilcon C, smafilcon A, somofilcon A, and stenfilcon A. These can be used as lens-forming compositions.

[0110] According to the present invention, a lens forming composition for forming a silicone hydrogel bulk material comprises (1) at least one polysiloxane vinyl monomer and / or at least one polysiloxane vinyl crosslinker and (2) at least one hydrophilic vinyl monomer.

[0111] Any polysiloxane vinyl monomer can be used in the present invention. Examples of preferred polysiloxane vinyl monomers include, but are not limited to, those of formula (M1) described later in this application and available from commercial suppliers (e.g., Shin-Etsu, Galester, etc.): those prepared according to the procedures described in patents, such as U.S. Pat. Nos. 5,070,215, 6,166,236, 6,867,245, 8,415,405, 8,475,529, 8,614,261, and 9,217,813; those prepared by reacting hydroxyalkyl (meth)acrylates or (meth)acrylamides or (meth)acryloyloxypolyethylene glycols with mono-glycidoxypropyl-terminated polydimethylsiloxane; those prepared by reacting glycidyl (meth)acrylate with mono-carbinol-terminated polydimethylsiloxane, mono-aminopropyl-terminated polydimethylsiloxane, or mono-ethylaminopropyl-terminated polydimethylsiloxane; and those prepared by reacting isocyanoethyl (meth)acrylate with mono-carbinol-terminated polydimethylsiloxane according to coupling reactions well known to those skilled in the art.

[0112] Any suitable polysiloxane vinyl crosslinking agent can be used in the present invention. Examples of preferred polysiloxane vinyl crosslinking agents include, but are not limited to: polysiloxane vinyl crosslinking agents, each of which comprises a hydrophilized siloxane unit having a methyl substituent and an organic group including at least one H-bond donor (preferably a hydroxyl group); di(meth)acryloyl-terminated polydimethylsiloxane; divinyl carbonate-terminated polydimethylsiloxane; divinylcarbamate-terminated polydimethylsiloxane; N,N,N',N'-tetrakis(3-methacryloyloxy-2-hydroxypropyl)-α,ω-bis-3-aminopropyl-polydimethylsiloxane; selected from US 5,760,100; disclosed in U.S. Patent Nos. 4,136,250, 4,153,641, 4,182,822, 4,189,546, 4,343,927, 4,254,248, 4,355,147, 4,276,402, 4,327,203, 4,341,889, 4,486,577, 4,543,398, 4,605,712, 4,661,575, 4,684,538, 4,703,097, 4,833,218, 4837289, 4954586, 4954587, 5010141, 5034461, 5070170, 5079319, 5039761, 5346946, 5358995, 5387632, 5416132, 5451617, 5486579, 5962548, 5981675, 6039913, and 6762264; and the polysiloxane-containing macromonomers disclosed in U.S. Pat. Nos. 4,259,467, 4,260,725, and 4,261,875.

[0113] A preferred class of polysiloxane vinyl crosslinkers are di(meth)acryloyl-terminated polysiloxane vinyl crosslinkers, each of which has dimethylsiloxane units and hydrophilized siloxane units (each of which has a methyl substituent and a monovalent C₄-C₄₀ organic group substituent having 2 to 6 hydroxyl groups), more preferably polysiloxane vinyl crosslinkers of formula (G), as described later in this application. These can be prepared according to the procedures disclosed in U.S. Patent No. 10,081,697.

[0114] Another preferred class of polysiloxane vinyl crosslinkers is the following vinyl crosslinkers, each comprising a single polydiorganosiloxane segment and two terminal (meth)acryloyl groups, which are available from commercial suppliers; prepared by reacting glycidyl (meth)acrylate (meth)acryloyl chloride with di-amino-terminated polydimethylsiloxane or di-hydroxy-terminated polydimethylsiloxane; prepared by reacting isocyanatoethyl (meth)acrylate with di-hydroxy-terminated polydimethylsiloxane; prepared by reacting an amine-containing acrylic monomer with a di-carboxyl-terminated polydimethylsiloxane in the presence of a coupling agent (carbodiimide); prepared by reacting a carboxyl-containing acrylic monomer with a di-amine-terminated polydimethylsiloxane in the presence of a coupling agent (carbodiimide); or prepared by reacting a hydroxyl-containing acrylic monomer with a di-hydroxy-terminated polydisiloxane in the presence of a diisocyanate or di-epoxy coupling agent.

[0115] Other preferred classes of polysiloxane vinyl crosslinkers include chain-extended polysiloxane vinyl crosslinkers, each having at least two polydiorganosiloxane segments connected by a linker between each pair of polydiorganosiloxane segments and two terminal ethylenically unsaturated groups. These can be prepared according to the procedures described in U.S. Patent Nos. 5,034,461, 5,416,132, 5,449,729, 5,760,100, 7,423,074, 8,529,057, 8,835,525, 8,993,651, 1,030,1451, and 1,0465,047.

[0116] Preferably, the lens-forming composition for forming the silicone hydrogel bulk material comprises at least one first polysiloxane vinyl crosslinker comprising hydrophilized siloxane units each having a methyl substituent and an organic group including at least one H-bond donor, preferably a hydroxyl group.

[0117] Any hydrophilic vinylic monomer may be used in the present invention. Examples of preferred hydrophilic vinyl monomers are alkyl (meth) acrylamides (as described later in this application), hydroxyl group-containing acrylic monomers (described below), amine group-containing acrylic monomers (as described later in this application), carboxyl group-containing acrylic monomers (as described later in this application), N-vinylamide monomers (as described later in this application), methylene group-containing pyrrolidone monomers (i.e., pyrrolidone derivatives each having a methylene group attached to the pyrrolidone ring at the 3-position or 5-position) (as described later in this application), acrylic monomers having a C1-C4 alkoxyethoxy group (as described later in this application), vinyl ether monomers (as described later in this application), allyl ether monomers (as described later in this application), phosphocholine-containing vinyl monomers (as described later in this application), N-2-hydroxyethyl vinyl carbamate, N-carboxyvinyl-β-alanine (VINAL), N-carboxyvinyl-α-alanine, and combinations thereof.

[0118] According to the present invention, the lens-forming composition used to form the silicone hydrogel bulk material may further include at least one silicone-containing vinylic monomer having a bis(trialkylsiloxy)alkylsilyl group or a tri(trialkylsiloxy)silyl group. Examples of such preferred silicone-containing vinylic monomers include, but are not limited to, those of formula (M2), which are described later in this application and can be obtained from commercial suppliers (e.g., Shin-Etsu Corporation, Galester Corporation, etc.) or prepared according to the procedures described in U.S. Patent Nos. 5,070,215, 6,166,236, 7,214,809, 8,475,529, 8,658,748, 9,097,840, 9,103,965, and 9,475,827.

[0119] According to the present invention, the lens forming composition used to form the silicone hydrogel bulk material may further include one or more hydrophobic non-silicone vinyl monomers. Examples of preferred hydrophobic non-silicone vinyl monomers include non-silicone hydrophobic acrylic monomers (methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, isopropyl (meth)acrylate, cyclohexyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, isobornyl (meth)acrylate, (meth)acrylonitrile, etc.), fluorine-containing acrylic monomers (e.g., perfluorohexylethyl-thio-carbonyl-aminoethyl-methacrylate, the perfluoro-substituted-C2-C12 alkyl (meth)acrylates described below, etc.), vinyl alkanoates (e.g., vinyl acetate, vinyl propionate, vinyl butyrate, vinyl valerate, etc.), vinyloxyalkanes (e.g., vinyl ethyl ether, propyl vinyl ether, n-butyl vinyl ether, isobutyl vinyl ether, cyclohexyl vinyl ether, tertiary butyl vinyl ether, etc.), styrene, vinyltoluene, vinyl chloride, vinylidene chloride, 1-butene, and combinations thereof.

[0120] Any suitable perfluoro-substituted-C2-C12 alkyl (meth)acrylate can be used in the present invention. Examples of perfluoro-substituted-C2-C12 alkyl (meth)acrylates include, but are not limited to, 2,2,2-trifluoroethyl (meth)acrylate, tetrafluoropropyl (meth)acrylate, hexafluoro-isopropyl (meth)acrylate, hexafluorobutyl (meth)acrylate, heptafluorobutyl (meth)acrylate, octafluoropentyl (meth)acrylate, heptadecafluorodecyl (meth)acrylate, pentafluorophenyl (meth)acrylate, and combinations thereof.

[0121] According to the present invention, the lens-forming composition used to form the silicone hydrogel bulk material may further include one or more non-silicone vinyl crosslinking agents. Examples of preferred non-silicone vinyl crosslinking agents are described later in this application.

[0122] According to the present invention, the lens-forming composition used to form the silicone hydrogel bulk material may further include other polymerizable materials, such as UV-absorbing vinylic monomers, UV / high-energy violet light ("HEVL")-absorbing vinylic monomers, polymerizable photochromic compounds, polymerizable colorants (polymerizable dyes), or combinations thereof, as known to those skilled in the art.

[0123] Any suitable UV-absorbing vinylic monomer and UV / HEVL-absorbing vinylic monomer can be used in the polymerizable composition used to prepare the preformed SiHy contact lens of the present invention. Examples of preferred UV-absorbing vinylic monomers and UV / HEVL-absorbing vinylic monomers include, but are not limited to, 2-(2-hydroxy-5-vinylphenyl)-2H-benzotriazole, 2-(2-hydroxy-5-acryloxyphenyl)-2H-benzotriazole, 2-(2-hydroxy-3-methacrylamidomethyl-5-tert-octylphenyl)benzotriazole, 2-(2'-hydroxy-5'-methacrylamidophenyl)-5-chlorobenzotriazole, 2-(2'-hydroxy-5'-methacrylamidophenyl)-5-methoxybenzotriazole, and 1,1-dextrin. azole, 2-(2'-hydroxy-5'-methacryloyloxypropyl-3'-tert-butyl-phenyl)-5-chlorobenzotriazole, 2-(2'-hydroxy-5'-methacryloyloxypropylphenyl)benzotriazole, 2-hydroxy-5-methoxy-3-(5-(trifluoromethyl)-2H-benzo[d][1,2,3]triazol-2-yl)benzyl methacrylate (WL-1), 2-hydroxy-5-methoxy-3-(5-methoxy-2H-benzo[d][1,2,3]triazol-2-yl)benzyl methacrylate (WL-5 ), 3-(5-fluoro-2H-benzo[d][1,2,3]triazol-2-yl)-2-hydroxy-5-methoxybenzyl methacrylate (WL-2), 3-(2H-benzo[d][1,2,3]triazol-2-yl)-2-hydroxy-5-methoxybenzyl methacrylate (WL-3), 3-(5-chloro-2H-benzo[d][1,2,3]triazol-2-yl)-2-hydroxy-5-methoxybenzyl methacrylate (WL-4), 2-hydroxy-5-methoxy-3-(5-methyl-2H-benzo[d][1,2,3]triazol-2-yl)-2-hydroxy-5-methoxybenzyl methacrylate (WL-5), 2-[d][1,2,3]triazol-2-yl]benzyl methacrylate (WL-6), 2-hydroxy-5-methyl-3-(5-(trifluoromethyl)-2H-benzo[d][1,2,3]triazol-2-yl)benzyl methacrylate (WL-7), 4-allyl-2-(5-chloro-2H-benzo[d][1,2,3]triazol-2-yl)-6-methoxyphenol (WL-8), 2-{2'-hydroxy-3'-tert-5'[3"-(4"-vinylbenzyloxy)propoxy]phenyl}-5-methoxy- 2H-Benzotriazole, phenol, 2-(5-chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-vinyl-(UVAM), 2-[2'-hydroxy-5'-(2-methacryloyloxyethyl)phenyl)]-2H-benzotriazole (2-propenoic acid, 2-methyl-, 2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl ester,Norbloc), 2-{2'-hydroxy-3'-tert-butyl-5'-[3'-methacryloyloxypropoxy]phenyl}-2H-benzotriazole, 2-{2'-hydroxy-3'-tert-butyl-5'-[3'-methacryloyloxypropoxy]phenyl}-5-methoxy-2H-benzotriazole (UV13), 2-{2'-hydroxy-3'-tert-butyl-5'-[3'-methacryloyloxypropoxy]phenyl}-5-chloro-2H-benzotriazole (UV28), 2-[2'-hydroxy-3'-tert-butyl-5'-(3'-acryloyloxypropoxy)phenyl]-5-trifluoromethyl- 2H-Benzotriazole (UV23), 2-(2'-Hydroxy-5-methylacrylamidophenyl)-5-methoxybenzotriazole (UV6), 2-(3-allyl-2-hydroxy-5-methylphenyl)-2H-benzotriazole (UV9), 2-(2-hydroxy-3-methylallyl-5-methylphenyl)-2H-benzotriazole (UV12), 2-3'-tert-butyl-2'-hydroxy-5'-(3"-dimethylvinylsilylpropoxy)-2'-hydroxy-phenyl)-5-methoxybenzotriazole (UV15), 2-(2'-Hydroxy-5'-methacrylamidophenyl)-3'-tert-butyl-phenyl)-5-methoxy- 2H-Benzotriazole (UV16), 2-(2'-Hydroxy-5'-acryloylpropyl-3'-tert-butyl-phenyl)-5-methoxy-2H-benzotriazole (UV16A), 2-methacrylate, 3-[3-tert-butyl-5-(5-chlorobenzotriazol-2-yl)-4-hydroxyphenyl]-propyl ester (16-100, CAS # 96478-15-8), 2-(3-(tert-butyl)-4-hydroxy-5-(5-methoxy-2H-benzo[d][1,2,3]triazol-2-yl)phenoxy)ethyl methacrylate (16-102); phenol, 2-(5-chloro-2H-benzotriazol-2-yl)-6-methoxy-4-(2-propen-1-yl) (CAS # 1260141-20-5); 2-[2-hydroxy-5-[3-(methacryloyloxy)propyl]-3-tert-butylphenyl]-5-chloro-2H-benzotriazole; phenol, 2-(5-vinyl-2H-benzotriazol-2-yl)-4-methyl-, homopolymer (9CI) (CAS # 83063-87-0). According to the present invention, the polymerizable composition contains one or more UV-absorbing vinyl monomers in an amount of about 0.1% to about 3.0%, preferably about 0.2% to about 2.5%, and more preferably about 0.3% to about 2.0% by weight relative to all polymerizable components in the polymerizable composition.

[0124] Examples of preferred photochromic vinyl monomers include polymerizable naphthopyran, polymerizable benzopyran, polymerizable indenonaphthopyran, polymerizable phenanthropyran, polymerizable spiro(benzoindoline)-naphthopyran, polymerizable spiro(indoline)benzopyran, polymerizable spiro(indoline)-naphthopyran, polymerizable spiro(indoline)quinopyran, polymerizable spiro(indoline)-pyran, polymerizable phenanthroquinopyran, polymerizable spiro(indoline)-pyran, polymerizable phenanthroquinopyran, polymerizable spirobenzopyran; polymerizable spirobenzopyran, polymerizable spirobenzothiopyran, polymerizable naphthonaphthalenedione, polymerizable spiro, polymerizable spiro(indoline)phenanthroquinopyran, polymerizable spiro(indoline)pyridobenzopyran, polymerizable spiro(benzo ... pyridobenzophenones, polymerizable spiro(benzidinol)phenones, polymerizable spiro(indoline)-benzophenones, polymerizable diarylethenes, and combinations thereof, as disclosed in U.S. Patent Nos. 4,929,693, 5,166,345, 6,017,121, 7,556,750, 7,584,630, 7,999,989, 8,158,037, 8,697,770, 8,741,188, 9,052,438, 9,097,916, 9,465,234, 9,904,074, 1,019,7707, 6,019,914, 6,113,814, 6,149,841, 6,296,785, and 6,348,604.

[0125] According to the present invention, the silicone hydrogel material formed has an equilibrium water content (i.e., in a fully hydrated state or when fully hydrated) of from about 20% to about 70% by weight (preferably from about 20% to about 65%, more preferably from about 25% to about 65%, and even more preferably from about 30% to about 60%), an oxygen permeability of at least about 40 barrers (preferably at least about 60 barrers, more preferably at least about 80 barrers, and even more preferably at least about 100 barrers), and a modulus (i.e., Young's modulus) of about 1.5 MPa or less (preferably from about 0.2 MPa to about 1.2 MPa, more preferably from about 0.3 MPa to about 1.1 MPa, and even more preferably from about 0.4 MPa to about 1.0 MPa).

[0126] According to the present invention, the lens forming composition of the present invention must contain a free radical initiator, which is a thermal free radical initiator or a free radical photoinitiator. Any of those described above or known to those skilled in the art can be used in the present invention.

[0127] The lens-forming compositions of the present invention can be prepared by dissolving or blending all desired components (or materials) in the presence or absence of a non-reactive diluent (solvent) as described later in this application.

[0128] The lens-forming composition or insert-forming composition can be a solvent-free, transparent liquid prepared by mixing all polymerizable components (or materials) with other necessary components (materials), or a solution prepared by dissolving all necessary components (materials) in any suitable solvent known to those skilled in the art, such as a mixture of water and one or more water-miscible organic solvents, an organic solvent, or a mixture of one or more organic solvents. The term "solvent" or "non-reactive diluent" refers to a chemical that does not participate in the free radical polymerization reaction.

[0129] Solvent-free SiHy lens formulations (silicone hydrogel lens-forming compositions) typically include at least one co-blended vinylic monomer as a reactive solvent for dissolving all other polymerizable components of the solvent-free SiHy lens formulation. Examples of preferred co-blended vinylic monomers are described later in this application. Preferably, methyl methacrylate is used as the co-blended vinylic monomer in preparing the solvent-free SiHy lens formulation.

[0130] Examples of suitable solvents include, but are not limited to, acetone, methanol, cyclohexane, tetrahydrofuran, tripropylene glycol methyl ether, dipropylene glycol methyl ether, ethylene glycol n-butyl ether, ketones (e.g., acetone, methyl ethyl ketone, etc.), diethylene glycol n-butyl ether, diethylene glycol methyl ether, ethylene glycol phenyl ether, propylene glycol methyl ether, propylene glycol methyl ether acetate, dipropylene glycol methyl ether acetate, propylene glycol n-propyl ether, dipropylene glycol n-propyl ether, tripropylene glycol n-butyl ether, propylene glycol n-butyl ether, dipropylene glycol n-butyl ether, tripropylene glycol n-butyl ether, propylene glycol phenyl ether, dipropylene glycol dimethyl ether, polyethylene glycol, polypropylene glycol, ethyl acetate, butyl acetate, amyl acetate, Esters, methyl lactate, ethyl lactate, isopropyl lactate, dichloromethane, 2-butanol, 1-propanol, 2-propanol, menthol, cyclohexanol, cyclopentanol and exonorborneol, 2-pentanol, 3-pentanol, 2-hexanol, 3-hexanol, 3-methyl-2-butanol, 2-heptanol, 2-octanol, 2-nonanol, 2-decanol, 3-octanol, norborneol, tertiary butyl alcohol, tertiary pentyl alcohol, alcohol, 2-methyl-2-pentanol, 2,3-dimethyl-2-butanol, 3-methyl-3-pentanol, 1-methylcyclohexanol, 2-methyl-2-hexanol, 3,7-dimethyl-3-octanol, 1-chloro-2-methyl- 2-Propanol, 2-methyl-2-heptanol, 2-methyl-2-octanol, 2-methyl-2-nonanol, 2-methyl-2-decanol, 3-methyl-3-hexanol, 3-methyl-3-heptanol, 4-methyl-4-heptanol, 3-methyl-3-octanol, 4-methyl-4-octanol, 3-methyl-3-nonanol, 4-methyl-4-nonanol, 3-methyl-3-octanol, 3-ethyl-3-hexanol, 3-methyl-3-heptanol, 4-ethyl-4-heptanol, 4-propyl-4-heptanol, 4-isopropyl-4-heptanol, 2,4-dimethyl-2-pentanol, 1-methylcyclopentanol, 1-ethylcyclopentanol, 1-ethylcyclopentanol Pentanol, 3-hydroxy-3-methyl-1-butene, 4-hydroxy-4-methyl-1-cyclopentanol, 2-phenyl-2-propanol, 2-methoxy-2-methyl-2-propanol, 2,3,4-trimethyl-3-pentanol, 3,7-dimethyl-3-octanol, 2-phenyl-2-butanol, 2-methyl-1-phenyl-2-propanol and 3-ethyl-3-pentanol, 1-ethoxy-2-propanol, 1-methyl-2-propanol, tertiary pentanol, isopropyl alcohol, 1-methyl-2-pyrrolidone, N,N-dimethylpropionamide, dimethylformamide, dimethylacetamide, dimethylpropionamide, N-methylpyrrolidone, and mixtures thereof. More preferred organic solvents include, but are not limited to, methanol, ethanol, 1-propanol, isopropanol, secondary butanol, tertiary butanol, tertiary amyl alcohol, acetone, methyl ethyl ketone, methyl isopropyl ketone, methyl propyl ketone, ethyl acetate, heptane, methylhexane (various isomers), methylcyclohexane, dimethylcyclopentane (various isomers), 2,2,4-trimethylpentane, and mixtures thereof.

[0131] The insert-forming composition and the lens-forming composition may be introduced into the insert molding cavity and the lens molding cavity, respectively, according to any technique known to those skilled in the art.

[0132] According to a preferred embodiment of the present invention, the insert is placed in the female lens mold half in a manner that ensures that the central axis of the insert coincides with the central axis of the female lens mold half according to any technique known to those skilled in the art. Examples of preferred systems for insert placement and positioning include, but are not limited to, those described in co-pending U.S. patent application Ser. No. 18 / 070,189, filed on November 29, 2022, entitled "SYSTEMS AND METHODS FOR INSERT PLACEMENT TO FABRICATE HYBRID CONTACT LENSES."

[0133] When the first molding assembly is closed, any excess insert-forming composition is pressed into one or more overflow areas (eg, grooves) provided on one of the insert mold halves.

[0134] When the second molding assembly is closed, any excess lens forming composition is pressed into one or more overflow areas (eg, grooves) provided on one of the insert mold halves.

[0135] The overflow groove surrounds a molding surface that defines one of a front surface and a back surface of a contact lens to be molded.

[0136] As is known to those skilled in the art, curing of the insert-forming composition within the insert-molding cavity of the closed first molding component is performed thermally (ie, by heating) to activate the polymerization initiator.

[0137] For example, as is well known to those skilled in the art, thermal curing of the insert-forming composition in the insert mold or thermal curing of the lens-forming composition in the lens mold can be conveniently carried out in an oven at one or more temperatures of from 25°C to 120°C, and preferably from 40°C to 100°C. The reaction time can vary widely, but is suitably, for example, from 1 to 24 hours or preferably from 2 to 12 hours. It is advantageous to pre-degas the insert-forming composition and to carry out the polymerization reaction under an inert atmosphere, such as an N2 or Ar atmosphere.

[0138] As is well known to those skilled in the art, curing of the insert-forming composition in the insert mold or curing of the lens-forming composition in the lens mold can be performed actinically (i.e., by actinic radiation, e.g., UV radiation and / or visible radiation) to activate the polymerization initiator.

[0139] After the curing step, the steps of opening the mold (i.e., separating the male insert (lens) mold half from the female insert (lens) mold half, wherein the insert (or lens-embedded hydrogel lens precursor) is attached to one of the male insert (lens) mold half and the female insert (lens) mold half) and de-lensing (i.e., removing the insert (embedded hydrogel lens precursor) from the insert-adhered or lens-adhered mold half) are performed according to any technique known to a skilled person.

[0140] The step of separating the first molded component can be performed using any technique known to those skilled in the art. It should be understood that the molded insert adheres to one of the female insert mold half and the male insert mold half. Many techniques are known in the art. For example, the molding surface of the insert mold half designed to adhere to the molded insert can be surface treated to cause the molded insert to preferentially adhere to the molding surface of the insert mold half. Alternatively, a compressive force can be applied to the non-optical surface (opposite the molding surface) of the insert mold half (to which the molded insert is not adhered) of the first molded component using a mold opening device at a location around the central region of the non-optical molding surface at an angle of less than about 30 degrees, preferably less than about 10 degrees, and most preferably less than about 5 degrees relative to the axis of the insert mold (i.e., in a direction substantially orthogonal to the central region of the non-optical molding surface) to deform the insert mold half, thereby breaking the bond between the molding surface of the insert mold half and the molded insert. There are various ways to apply a force to the non-optical surface of the insert mold half at locations around the central region of the non-optical molding surface along the axis of the insert mold to deform the insert mold half and break the bond between the optical molding surface of the insert mold half and the molded insert. It should be understood that the mold opening device can have any configuration known to those skilled in the art to perform the function of separating the two mold halves from each other.

[0141] Similarly, the step of separating the second mold assembly can be performed according to any technique known to those skilled in the art. It should be understood that the molded embedded hydrogel lens precursor can be adhered to either of the two lens mold halves of the second mold assembly.

[0142] After the embedded hydrogel lens precursor has been delensed, it is typically extracted with an extraction medium, such as is well known to those skilled in the art. The extraction liquid medium is any solvent capable of dissolving one or more of the diluent, unpolymerized polymerizable material, and oligomers in the embedded hydrogel lens precursor. Water, any organic solvent known to those skilled in the art, or mixtures thereof can be used in the present invention. Preferably, the organic solvent used as the extraction liquid medium is water, buffered saline, a C1-C3 alkyl alcohol, 1,2-propylene glycol, polyethylene glycol having a number average molecular weight of approximately 400 Daltons or less, a C1-C6 alkyl alcohol, or a combination thereof.

[0143] The extracted embedded hydrogel contact lens can then be hydrated according to any method known to those skilled in the art.

[0144] The hydrated embedded hydrogel contact lens can be further subjected to other processes such as, for example, surface treatment, packaging in lens packaging using packaging solutions well known to those skilled in the art; sterilization, such as autoclaving at from 118°C to 124°C for at least about 30 minutes; and the like.

[0145] Lens packages (or containers) are well known to those skilled in the art for autoclaving and storing soft contact lenses. Any lens package can be used in the present invention. Preferably, the lens package is a blister package comprising a base and a cover, wherein the cover is removably sealed to the base, wherein the base includes a cavity for receiving a sterile packaging solution and a contact lens.

[0146] The lenses are packaged in individual packages, sealed, and sterilized (e.g., by autoclaving under pressure at about 120°C or higher for at least 30 minutes) prior to distribution to users. Those skilled in the art will have a good understanding of how to seal and sterilize lens packages.

[0147] Although various embodiments of the present invention have been described using specific terms, devices, and methods, such descriptions are for illustrative purposes only. The words used are descriptive rather than limiting. As should be apparent to those skilled in the art, many variations and modifications of the present invention may be made by those skilled in the art without departing from the spirit and scope of the novel concepts disclosed herein. Furthermore, it should be understood that various aspects of the various embodiments of the present invention may be interchanged in whole or in part or may be combined and / or used together in any manner, as illustrated below: 1. A method for producing an embedded hydrogel contact lens, the method comprising the following steps: (1) obtaining an insert mold, wherein the insert mold includes a male insert mold half having a first molding surface and a female insert mold half having a second molding surface, the male insert mold half and the female insert mold half being configured to receive each other so that an insert molding cavity is formed between the first molding surface and the second molding surface when the female insert mold half and the male insert mold half are closed; (2) dispensing an insert-forming composition into the female insert mold half, wherein the insert-forming composition comprises (i) at least one polymerizable material, (ii) at least one first free radical initiator, and (iii) at least one iniferter; (3) closing the female insert mold half and the male insert mold half to form a first molded assembly, the first molded assembly including the insert forming composition within the insert molding cavity of the insert mold; (4) thermally or actinically curing the insert-forming composition in the insert-molding cavity of the first molding assembly to form a molded insert made of a first cross-linked polymeric material comprising an iniferter moiety covalently attached thereto; (5) obtaining a lens mold and a lens forming composition, wherein the lens mold includes a male lens mold half having a third molding surface and a female lens mold half having a fourth molding surface, the male lens mold half and the female lens mold half being configured to receive each other such that a lens molding cavity is formed between the third molding surface and the fourth molding surface when the female lens mold half is closed with the male lens mold half, wherein the lens forming composition comprises at least a second polymerizable material and a second free radical initiator; (6) placing the insert obtained in step (4) at a desired location in the female lens mold half, in no particular order, and dispensing the lens forming composition in the female lens mold half, wherein the insert is immersed in the lens forming composition; (7) closing the female lens mold half with the male lens mold half to form a second molded assembly, the second molded assembly comprising the lens forming composition in the lens molding cavity of the lens mold and the insert immersed therein; (8) thermally or actinically curing the lens forming composition in the lens molding cavity of the second molding assembly while simultaneously initiating iniferter-induced polymerization of the lens forming composition at and near a surface of the insert to form an embedded hydrogel lens precursor comprising a bulk hydrogel material formed from the lens forming composition and the insert embedded in the bulk material, wherein the bulk hydrogel material is a second cross-linked polymeric material covalently linked to the first cross-linked polymeric material at iniferter moieties located at and near a surface of the insert; (9) separating the lens mold obtained in step (8) into the male lens half mold and the female lens half mold, wherein the embedded hydrogel lens precursor is adhered to the lens-adhered lens half mold, and the lens-adhered lens half mold is one of the male lens half mold and the female lens half mold; (10) removing the embedded hydrogel lens precursor from the lens mold half to which the lens is adhered (preferably before the embedded hydrogel lens precursor comes into contact with water or any liquid); and (11) subjecting the embedded hydrogel lens precursor to a post-molding process to form the embedded hydrogel contact lens, the process comprising a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof. 2. The method of embodiment 1, wherein the at least one iniferter comprises a thiocarbonylthio-containing compound (i.e., having a thiocarbonylthio moiety). ). 3. The method of embodiment 2, wherein the at least one thiocarbonylthio-containing compound is a dithioester, a dithiocarbamate, a dithioester, a trithiocarbonate, a xanthate, a thiuram monosulfide, a thiuram disulfide, a xanthate disulfide, or a combination thereof. 4. The method of embodiment 1, wherein the at least one iniferter comprises at least one thiocarbonylthio-containing compound selected from the group consisting of thiuram monosulfide, N,N'-dimethylthiuram monosulfide, N,N,N',N'-tetramethylthiuram monosulfide, N,N'-diethylthiuram monosulfide, N,N,N',N'-tetraethylthiuram monosulfide, thiuram disulfide, N,N-dimethylthiuram disulfide, N,N'-diethylthiuram disulfide, N,N'-diethyl-N,N'-bis(2-hydroxyethyl)thiuram disulfide, N,N'-bis(N-(2-phthalimidoethyl)piperidinium-thiuram disulfide), N,N'-dimethylthiuram tetrasulfide, tetramethylthiuram disulfide, tetraethylthiuram disulfide, tetraisopropylthiuram disulfide, N,N'-dimethyl N,N'-di(4-pyridyl)thiuram disulfide, bis(thiobenzoyl) disulfide, diisopropyl xanthate disulfide, dithiobenzoic acid cyanomethyl ester, dithiobenzoic acid benzyl ester, dithiobenzoic acid 2-phenyl-2-propyl ester, bis(thiobenzoyl) disulfide, 1 Benzyl H-pyrrole-1-dithiocarboxylate, 2-cyano-2-propyl dithiobenzoate, bis(carboxymethyl)trithiocarbonate, 4-cyano-4-(thiobenzoylthio)pentanoic acid, ethyl 2-(phenylthiocarbonylthio)-2-phenylacetate, ethyl 2-(phenylthiocarbonylthio)-propionate, 1-(methoxycarbonyl)ethyl dithiobenzoate, 2-cyano-2-propyl 4-cyanodithiobenzoate, ethyl 2-(4-methoxyphenylthiocarbonylthio)acetate, ethyl 2-methyl-2-(phenylthiocarbonylthio)propionate, ethyl 2-(phenylthiocarbonylthio)-2-phenylacetate, 2-(4-methoxyphenylthiocarbonylthio)acetate, 4-cyano-4-(phenyl 2-nitro-5-(2-propynyloxy)benzyl thiocarbonyl) pentanoate, S,S-bis(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, S-dodecyl-S′-(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, S-ethyl-S′-(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, 4-cyano-4-ethyl-trithiopentanoic acid, S,S-dibenzyl trithiocarbonate, bis(carboxymethyl) trithiocarbonate, dimethyl trithiocarbonate, o-phthalimidomethylbutyl trithiocarbonate, cyanomethyldodecyl trithiocarbonate, 4-cyano-4-[(dodecylhydrothiothiocarbonyl)hydrothio]pentanoic acid, 3,5-Bis(2-dodecylthiothiocarbonylthio-1-oxopropyl)benzoic acid, 2-(2-carboxyethylthiothiocarbonylthio)-propionic acid, 2-cyano-2-propyldodecyl trithiocarbonate, 3-butenyl-2-(dodecylthiothiocarbonylthio)-2-methylpropanoate, 2-(dodecylthiothiocarbonylthio)-2-methylpropanoate, cyanomethyl (3,5-dimethyl-1H-pyrazole)-dithiocarboxylate, 2-cyanobutyl-2-yl 4-chloro-3,5-dimethyl-1H-pyrazole-1-dithiocarboxylate, methyl 2-[methyl(4-pyridyl)thiocarbamoylthio]propionate, 2-cyanobutyl-2-yl 3,5-dimethyl-1 H-pyrazole-1-dithiocarbamate, cyanomethylmethyl (phenyl)dithiocarbamate, cyanomethylmethyl (4-pyridyl)dithiocarbamate, benzyl 1H-pyrrole-1-dithiocarbamate, cyanomethyldiphenyldithiocarbamate, cyanomethylmethyl (4-pyridyl)dithiocarbamate, benzyl-N,N-dimethyldithiocarbamate, benzyl-N,N-diethyldithiocarbamate, 2-(N,N-diethyldithiocarbamate)isobutyric acid, ethyl 2-(N,N-diethyldithiocarbamate)isobutyrate, (4-cyano-4- diethyldithiocarbamoyl) valeric acid, 1-(ethoxycarbonyl)propan-1-yl dithiobenzoate, benzoylmethyl iodine-4-dithiocarbamoyl, S-2-cyano-2-propyl-O-ethyl xanthate, 1-phenylethylphenyl dithioacetate, S-methacryloyl O-ethyl xanthate, 2-(N,N-diethyldithiocarbamoyl)ethyl methacrylate, 2-(N,N-dimethylthiocarbamoyl)acetate ethyl dithiocarbamate), cyanopentanoic acid dithiobenzoate, 3-benzylthiocarbonylthiocarbonylpropionic acid, 2-(n-butyl trithiocarbonate)-propionic acid, n-butyl N,N-dimethyldithiocarbamate, benzyl dithiocarbamate, p-xylene bis(dithiocarbamate), p-xylene bis(N,N-dimethyldithiocarbamate), p-xylene bis(N,N-diethyldithiocarbamate), thiocarbamate), 1,2-bis(N,N-diethyldithiocarbamate)ethane, 1,2-bis(N,N-dimethyldithiocarbamate)ethane, 1,2,3-tris(N,N-dimethyldithiocarbamate)propane, 1,2,4,5-tetrakis(N,N-diethyldithiocarbamatemethyl)benzene, 1-(N,N-diethyldithiocarbamate)ethyl acetate, and combinations thereof. 5. The method of embodiment 1, wherein the at least one iniferter comprises at least one organic nitrogen oxide compound (i.e., having a nitrogen oxide moiety) ). 6. The method of embodiment 5, wherein the at least one organic nitrogen oxide compound is selected from the group consisting of: ((2',2',6',6'-tetramethyl-1'-piperidinyloxy)methyl)benzene, 1-phenyl-1-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)ethane, 1-(4'-bromophenyl)-1-(2",2",6",6"-tetramethyl-1"-piperidinyloxy)ethane, 1-naphthyl-1-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)ethane, 1-phenyl-1-(2',2',6',6'-tetramethyl-1'-piperidinyloxy)ethane, , 2',6',6'-tetramethyl-1-piperidinyloxy) propane, 1-(benzyloxy)-2-phenyl-2-(2',2',6',6'-tetramethyl-1'-piperidinyloxy) ethane, 1-hydroxy-2-phenyl-2-(2',2',6',6'-tetramethyl-1-piperidinyloxy) ethane, 4-cyano-4-(2',2',6',6'-tetramethyl-1'-piperidinyloxy) phenyl pentanoate, 4-cyano-4-(2',2',6',6'-tetramethyl-1'-piperidinyloxy) pentanoic acid pentafluorophenyl ester, 3-phenyl-1- (2',2',6',6'-tetramethyl-1'-piperidinyloxy)propane, 1-((2',2',6',6'-tetramethyl-1'-piperidinyloxy)methyl)-4-(trifluoromethyl)benzene, 2-((4-benzoylphenyl)((1-methoxy-2-methyl-1-oxopropyl-2-yl)oxy)amino)-2-methylpropanoic acid methyl ester, 2,2,6,6-tetramethyl-1-piperidinyloxy, 2,2,5-trimethyl-4-phenyl-3-azahexane-3-nitroxide, N-tert-butyl-N-1-phenyl-2-methylpropyl-nitroxide compounds, N-tert-butyl-N-1-(2-naphthyl)-2-methylpropyl nitroxide, N-tert-butyl-N-1-diethylphosphonyl-2,2-dimethylpropyl nitroxide, N-tert-butyl-N-1-dibenzylphosphonyl-2,2-dimethylpropyl nitroxide, N-phenyl-N-1-diethylphosphonyl-2,2-dimethylpropyl nitroxide, N-phenyl-N-1-diethylphosphonyl-1-methylethyl nitroxide, N-(1-phenyl-2-methylpropyl)-N-1-diethyl-phosphonyl-1-methylethyl nitroxide, and combinations thereof. 7. The method of any one of embodiments 1 to 6, wherein the at least one first polymerizable material comprises at least one polymerizable photochromic compound (i.e., a photochromic vinylic monomer), at least one UV-absorbing vinylic monomer, at least one UV / HEVL-absorbing vinylic monomer, at least one fluorescent vinylic monomer, or a combination thereof. 8. The method of any one of embodiments 1 to 7, wherein the insert-forming composition further comprises at least one color filter material for correcting color blindness, a diffractive material, a high refractive index material, or a combination thereof. 9. The method of any one of embodiments 1 to 8, wherein the insert-forming composition is used to form a first polymerizable composition of a cross-linked polymethyl methacrylate comprising repeating units of methyl methacrylate and at least one vinyl cross-linking agent. 10. The method of any one of embodiments 1 to 8, wherein the insert-forming composition is used to form a second polymerizable composition of a cross-linked silicone polymer having a three-dimensional polymer network, being insoluble in water, and having an equilibrium water content of about 5% by weight or less. 11. The method of embodiment 10, wherein the cross-linked silicone polymer has an equilibrium moisture content of about 3% by weight or less (preferably about 2% by weight or less). 12. The method of any one of embodiments 1 to 8, wherein the insert-forming composition is a third polymerizable composition for forming a rigid breathable material. 13. The method of any one of embodiments 1 to 8, wherein the insert-forming composition is used to form a fourth polymerizable composition of a hydrophobic cross-linked acrylic material having an equilibrium water content of less than 5% by weight and comprising, relative to the total amount of the at least one first polymerizable material and the other polymerizable materials, at least 55% by mole of one or more acrylic monomers and / or one or more acrylic cross-linking agents, and at least about 6% by mole of at least one acrylic cross-linking agent and, optionally, at least one vinyl cross-linking agent other than an acrylic cross-linking agent. 14. The method of embodiment 13, wherein the hydrophobic cross-linked acrylic material has an equilibrium water content of about 4% by weight or less. 15. The method of embodiment 13, wherein the hydrophobic cross-linked acrylic material has an equilibrium water content of about 3% by weight or less. 16. The method of embodiment 13, wherein the hydrophobic cross-linked acrylic material has an equilibrium water content of about 2% by weight or less. 17. The method of any one of embodiments 13 to 16, wherein the insert-forming composition comprises at least about 65% by mole of the one or more acrylic monomers and / or the one or more acrylic cross-linking agents, relative to the total amount of the at least one first polymerizable material and the other polymerizable materials. 18. The method of any one of embodiments 13 to 16, wherein the insert-forming composition comprises at least about 70% by mole of the one or more acrylic monomers and / or the one or more acrylic cross-linking agents, relative to the total amount of the at least one first polymerizable material and the other polymerizable materials. 19. The method of any one of embodiments 13 to 16, wherein the insert-forming composition comprises at least about 75% by mole of the one or more acrylic monomers and / or the one or more acrylic cross-linking agents, relative to the total amount of the at least one first polymerizable material and the other polymerizable materials. 20. The method of any one of embodiments 13 to 19, wherein the insert-forming composition comprises at least about 20% by mole of the at least one acrylic crosslinker and, optionally, the at least one vinyl crosslinker other than the acrylic crosslinker, relative to the total amount of the at least one first polymerizable material and the other polymerizable materials. 21. The method of any one of embodiments 13 to 19, wherein the insert-forming composition comprises at least about 30% by mole of the at least one acrylic crosslinker and optionally the at least one vinyl crosslinker other than an acrylic crosslinker. 22. The method of any one of embodiments 13 to 19, wherein the insert-forming composition comprises at least about 35% by mole of the at least one acrylic crosslinker and optionally the at least one vinyl crosslinker other than an acrylic crosslinker. 23. The method of any one of embodiments 13 to 22, wherein the at least one acrylic crosslinking agent is ethylene glycol dimethacrylate; ethylene glycol diacrylate; 1,3-propylene glycol diacrylate; 1,3-propylene glycol dimethacrylate; 2,3-propylene glycol diacrylate; 2,3-propylene glycol dimethacrylate; 1,4-butanediol dimethacrylate; 1,4-butanediol diacrylate; 1,5-pentanediol dimethacrylate; 1,5-pentanediol diacrylate; 1,6-hexanediol dimethacrylate; 1,6-hexanediol diacrylate; diethylene glycol dimethacrylate; diethylene glycol diacrylate; triethylene glycol dimethacrylate; triethylene glycol diacrylate; tetraethylene glycol dimethacrylate; tetraethylene glycol diacrylate; N,N'-methylenebis(acrylamide); N , N'-methylenebis(methacrylamide); N,N'-ethylidenebis(acrylamide); N,N'-ethylidenebis(methacrylamide); N,N'-hexamethylenebisacrylamide; N,N'-hexamethylenebismethacrylamide; pentaerythritol triacrylate, pentaerythritol trimethacrylate, trimethylolpropane triacrylate, trimethylolpropane trimethacrylate, tris(2-hydroxyethyl)isocyanurate triacrylate, tris(2-hydroxyethyl)isocyanurate trimethacrylate, 1,3,5-triacryloyloxyhexahydro-1,3,5-tris(2-hydroxyethyl)isocyanurate trimethacrylate, 1,3,5-trimethacryloyloxyhexahydro-1,3,5-tris(2-hydroxyethyl)isocyanurate; pentaerythritol tetraacrylate, pentaerythritol tetramethacrylate, di(trimethylolpropane) tetraacrylate, di(trimethylolpropane) tetramethacrylate, or a combination thereof. 24. The method of embodiment 22, wherein the at least one acrylic crosslinking agent is allyl (meth)acrylate, pentaerythritol tetra(meth)acrylate, neopentyl glycol di(meth)acrylate, an aromatic crosslinking agent, triallyl isocyanurate, 2,4,6-triallyloxy-1,3,5-triazine, 1,2,4-trivinylcyclohexane, or a combination thereof. 25. The method of any one of embodiments 13 to 24, wherein the at least one ethylene-based crosslinking agent comprises divinylbenzene, 2-methyl-1,4-divinylbenzene, bis(4-vinylphenyl)methane, 1,2-bis(4-vinylphenyl)ethane, or a combination thereof. 26. The method of any one of embodiments 13 to 25, wherein the at least one first polymerizable material in the fourth polymerizable composition comprises at least one silicone-containing acrylic monomer. 27. The method of any one of embodiments 13 to 26, wherein the at least one first polymerizable material in the fourth polymerizable composition comprises at least one fluorine-containing acrylic monomer. 28. The method of embodiment 27, wherein the at least one fluorine-containing acrylic monomer is perfluorohexylethyl-thio-carbonyl-aminoethyl-methacrylate, 2,2,2-trifluoroethyl (meth)acrylate, tetrafluoropropyl (meth)acrylate, hexafluoro-isopropyl (meth)acrylate, hexafluorobutyl (meth)acrylate, heptafluorobutyl (meth)acrylate, octafluoropentyl (meth)acrylate, heptadecafluorodecyl (meth)acrylate, pentafluorophenyl (meth)acrylate, or a combination thereof. 29. The method of any one of embodiments 13 to 28, wherein the at least one first polymerizable material in the fourth polymerizable composition comprises at least one polysiloxane vinyl crosslinker. 30. The method of any one of embodiments 13 to 29, wherein the at least one first polymerizable material in the fourth polymerizable composition comprises at least one aromatic acrylic monomer having formula (I) or (II). (II) wherein A is H or CH (preferably H); B is (CH)m or [O(CH)]Z, wherein m is 2-6 and z is 1-10; Y is a direct bond, O, S, or NR', wherein R' is H, CH, Cn'H2n'+1 where n' = 1-10, iso-OC3H7, C6H5, or CH2C6H5; Ra, Rb, Rc, Rd, Re, Rf, Rg, Rh, and Ri are independently H, C1-C12 alkyl, or C1-C12 alkoxy (preferably all are H); w is 0-6, provided that m + w ≤ 8; w is an integer from 1 to 3; and D is H, Cl, Br, C1-C4 alkyl, C1-C 4 alkoxy, C 6H 5, or CH 2C 6H 5. 31. The method of embodiment 30, wherein the at least one aromatic acrylic monomer is selected from the group consisting of: 2-ethylphenoxy acrylate; 2-ethylphenoxy methacrylate; phenyl acrylate; phenyl methacrylate; benzyl acrylate; benzyl methacrylate; 2-phenylethyl acrylate; 2-phenylethyl methacrylate; 3-phenylpropyl acrylate; 3-phenylpropyl methacrylate; 4-phenylbutyl acrylate; 4-phenylbutyl methacrylate; 4-methylphenyl acrylate; 4-methylphenyl methacrylate; 4-methylbenzyl acrylate; 4-methylbenzyl methacrylate ;2-(2-methylphenyl)ethyl acrylate;2-(2-methylphenyl)ethyl methacrylate;2-(3-methylphenyl)ethyl acrylate;2-(3-methylphenyl)ethyl methacrylate;2-(4-methylphenyl)ethyl acrylate;2-(4-methylphenyl)ethyl methacrylate;2-(4-propylphenyl)ethyl acrylate;2-(4-propylphenyl)ethyl methacrylate;2-(4-(1-methylethyl)phenyl)ethyl acrylate;2-(4-(1-methylethyl)phenyl)ethyl methacrylate;2-(4-methoxyphenyl)ethyl acrylate;methyl acrylate 2-(4-Methoxyphenyl)ethyl acrylate;2-(4-cyclohexylphenyl)ethyl acrylate;2-(4-cyclohexylphenyl)ethyl methacrylate;2-(2-chlorophenyl)ethyl acrylate;2-(2-chlorophenyl)ethyl methacrylate;2-(3-chlorophenyl)ethyl acrylate;2-(3-chlorophenyl)ethyl methacrylate;2-(4-chlorophenyl)ethyl acrylate;2-(4-chlorophenyl)ethyl methacrylate;2-(4-bromophenyl)ethyl acrylate;2-(4-bromophenyl)ethyl methacrylate;2-(3-phenylphenyl)ethyl acrylate;2-(4-chlorophenyl)ethyl methacrylate (3-phenylphenyl)ethyl acrylate; 2-(4-phenylphenyl)ethyl acrylate; 2-(4-phenylphenyl)ethyl methacrylate; 2-(4-benzylphenyl)ethyl acrylate; 2-(4-benzylphenyl)ethyl methacrylate; 2-(phenylthio)ethyl acrylate; 2-(phenylthio)ethyl methacrylate; 2-benzyloxyethyl acrylate; 3-benzyloxypropyl acrylate; 2-benzyloxyethyl methacrylate; 3-benzyloxypropyl methacrylate; 2-[2-(benzyloxy)ethoxy]ethyl acrylate; 2-[2-(benzyloxy)ethoxy]ethyl methacrylate, and combinations thereof. 32. The method of any one of embodiments 13 to 31, wherein the at least one hydrophobic vinyl monomer is selected from the group consisting of vinyl alkanoates, vinyloxyalkanes, styrene, vinyltoluene, vinyl chloride, vinylidene chloride, 1-butene, and combinations thereof. 33. The method of any one of embodiments 13 to 32, wherein the hydrophobic insert is rigid. 34. The method of any one of embodiments 1 to 33, wherein the lens-forming composition comprises at least 50% by mole of at least one hydroxyl-containing vinylic monomer. 35. The method of embodiment 34, wherein the at least one hydroxyl-containing vinyl monomer is selected from the group consisting of hydroxyethyl (meth)acrylate, glycerol (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, N-2-hydroxyethyl (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris (hydroxymethyl)methyl (meth)acrylamide, vinyl alcohol, allyl alcohol, and combinations thereof. 36. The method of any one of embodiments 1 to 33, wherein the lens-forming composition comprises (a) at least one polysiloxane vinyl monomer and / or at least one first polysiloxane vinyl cross-linker and (b) at least one hydrophilic vinyl monomer. 37. The method of embodiment 36, wherein the lens forming composition comprises at least one hydrophilized polysiloxane vinyl crosslinker comprising hydrophilized siloxane units each having a methyl substituent and an organic group comprising at least one H-bond donor. 38. The method of embodiment 37, wherein the at least one hydrophilized polysiloxane vinyl crosslinker comprises hydrophilized siloxane units each having a methyl substituent and an organic group including at least one hydroxyl group. 39. The method of embodiment 37 or 38, wherein the at least one hydrophilized polysiloxane vinyl crosslinker comprises a di-(meth)acryloyloxy-terminated polysiloxane vinyl crosslinker having dimethylsiloxane units and hydrophilized siloxane units each having one methyl substituent and one monovalent C4-C40 organic group substituent having 2 to 6 hydroxyl groups. 40. The method of any one of embodiments 37 to 39, wherein the at least one hydrophilized polysiloxane vinyl crosslinker comprises a vinyl crosslinker having formula (G): in: d1 is an integer from 30 to 500 and d2 is an integer from 1 to 75, provided that d2 / d1 is from about 0.035 to about 0.15; X 01 is O or NR IN, wherein R IN is hydrogen or C 1-C 10-alkyl; R I0 is hydrogen or methyl; R I1 and R I2 are independently substituted or unsubstituted C 1-C 10 alkylene divalent groups or -R I4-OR I5- divalent groups, wherein R I4 and R I5 are independently substituted or unsubstituted C 1-C 10 alkylene divalent groups; R I3 is a monovalent group having any one of formulas (G-1) to (G-5) k1 is zero or 1; m1 is an integer from 2 to 4; m2 is an integer from 1 to 5; m3 is an integer from 3 to 6; m4 is an integer from 2 to 5; R I6 is hydrogen or methyl; R I7 is a C 2-C 6 hydrocarbon group having a valence of (m2 + 1); R I8 is a C 2-C 6 hydrocarbon group having a valence of (m4 + 1); R I9 is ​​ethyl or hydroxymethyl; R I10 is methyl or hydroxymethyl; R I11 is hydroxy or methoxy; X I1 is a sulfur linker -S- or a tertiary amino linker -NR I12-, wherein R I12 is a C 1-C 1 alkyl group, a hydroxyethyl group, a hydroxypropyl group or a 2,3-dihydroxypropyl group; and X I2 is an amide linker or , wherein R I13 is hydrogen or C 1-C 10 alkyl. 41. The method of any one of embodiments 36 to 40, wherein the lens-forming composition comprises: di-(meth)acryl-terminated polydimethylsiloxane, di-vinyl carbonate-terminated polydimethylsiloxane; di-vinylurethane-terminated polydimethylsiloxane; N,N,N',N'-tetrakis(3-methacryl-2-hydroxypropyl)-α,ω-bis-3-aminopropyl-polydimethylsiloxane, or a combination thereof. 42. The method of any one of embodiments 36 to 41, wherein the lens forming composition comprises: (1) an ethylene-based crosslinker comprising a sole polydiorganosiloxane segment and two terminal ethylenically unsaturated groups selected from the group consisting of (meth)acryloyloxy groups, (meth)acryloylamide groups, vinyl carbonate groups, and vinylurethane groups; and / or (2) a chain-extended polysiloxane ethylene-based crosslinker comprising at least two polydiorganosiloxane segments and a covalent linker between each pair of polydiorganosiloxane segments and two terminal ethylenically unsaturated groups selected from the group consisting of (meth)acryloyloxy groups, (meth)acryloylamide groups, vinyl carbonate groups, and vinylurethane groups. 43. The method of any one of embodiments 36 to 41, wherein the lens forming composition comprises: α,ω-bis[3-(meth)acrylamidopropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxyethoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxypropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidoethoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidoisopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidobutoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane Siloxane, α,ω-bis[3-(meth)acryloxyethylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxypropylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxybutylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acrylamideethylamino-2-hydroxypropoxy-propyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamide -butylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxy-2-hydroxypropoxy-ethoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxy-2-hydroxypropyl-N-ethylaminopropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxy-2-hydroxypropyl-aminopropyl]-polydimethylsiloxane, α,ω-bis[(meth)acryloyloxy-2-hydroxypropyl-(polyethyleneoxy)propyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxyethylamino-carbonyloxy-ethoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxyethylamino-carbonyloxy-(polyethyleneoxy)propyl]-terminated polydimethylsiloxane, or a combination thereof. 44. The method of any one of embodiments 36 to 43, wherein the at least one hydrophilic vinyl monomer comprises: (1) an alkyl (meth)acrylamide selected from the group consisting of (meth)acrylamide, N,N-dimethyl (meth)acrylamide, N-ethyl (meth)acrylamide, N,N-diethyl (meth)acrylamide, N-propyl (meth)acrylamide, N-isopropyl (meth)acrylamide, N-3-methoxypropyl (meth)acrylamide, and combinations thereof; (2) A hydroxyl-containing acrylic monomer selected from the group consisting of: N-2-hydroxyethyl (meth)acrylamide, N,N-bis(hydroxyethyl) (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris(hydroxymethyl)methyl (meth)acrylamide, 2-hydroxyethyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol) (meth)acrylate, tri(ethylene glycol) (meth)acrylate, tetra(ethylene glycol) (meth)acrylate, poly(ethylene glycol) (meth)acrylate having a number average molecular weight of up to 1500, poly(ethylene glycol)ethyl (meth)acrylamide having a number average molecular weight of up to 1500, and combinations thereof; (3) A carboxyl group-containing acrylic monomer selected from the group consisting of 2-(meth)acrylamidoglycolic acid, (meth)acrylic acid, ethacrylic acid, 3-(meth)acrylamidopropionic acid, 5-(meth)acrylamidopentanoic acid, 4-(meth)acrylamidobutyric acid, 3-(meth)acrylamido-2-methylbutyric acid, 3-(meth)acrylamido-3-methylbutyric acid, 2-(meth)acrylamido-2methyl-3,3-dimethylbutyric acid, 3-(meth)acrylamidohexanoic acid, 4-(meth)acrylamido-3,3-dimethylhexanoic acid, and combinations thereof; (4) An amino-containing acrylic monomer selected from the group consisting of: N-2-aminoethyl(meth)acrylamide, N-2-methylaminoethyl(meth)acrylamide, N-2-ethylaminoethyl(meth)acrylamide, N-2-dimethylaminoethyl(meth)acrylamide, N-3-aminopropyl(meth)acrylamide, N-3-methylaminopropyl(meth)acrylamide, N-3-dimethylaminopropyl(meth)acrylamide , 2-aminoethyl (meth)acrylate, 2-methylaminoethyl (meth)acrylate, 2-ethylaminoethyl (meth)acrylate, 3-aminopropyl (meth)acrylate, 3-methylaminopropyl (meth)acrylate, 3-ethylaminopropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate trimethylammonium hydrochloride, dimethylaminoethyl (meth)acrylate, and combinations thereof;(5) an N-vinylamide monomer selected from the group consisting of: N-vinylpyrrolidone (also known as N-vinyl-2-; [ , -, ]pyrrolidone), N-vinyl-3-methyl-2-pyrrolidone, N-vinyl-4-methyl-2-pyrrolidone, N-vinyl-5-methyl-2-pyrrolidone, N-vinyl-6-methyl-2-pyrrolidone, N-vinyl-3-ethyl-2-pyrrolidone, N-vinyl-4,5-dimethyl-2-pyrrolidone, N-vinyl-5,5-dimethyl-2-pyrrolidone, N-vinyl-3,3,5-trimethyl-2-pyrrolidone, N-vinylpiperidone (also known as, N-vinyl-2-piperidone), N-vinyl-3-methyl-2-piperidone, N-vinyl-4-methyl-2-piperidone, N-vinyl-5-methyl-2-piperidone, N-vinyl-6-methyl-2-piperidone, N-vinyl-6-ethyl-2-piperidone, N-vinyl- 3,5-dimethyl-2-piperidone, N-vinyl-4,4-dimethyl-2-piperidone, N-vinyl caprolactam (also known as N-vinyl-2-caprolactam), N-vinyl-3-methyl-2-caprolactam, N-vinyl-4-methyl-2-caprolactam, N-vinyl-7-methyl-2-caprolactam, N-vinyl-7-ethyl-2-caprolactam, N-vinyl- 3,5-Dimethyl-2-hexanolide, N-vinyl-4,6-dimethyl-2-hexanolide, N-vinyl-3,5,7-trimethyl-2-hexanolide, N-vinyl-N-methylacetamide, N-vinylformamide, N-vinylacetamide, N-vinylisopropylamide, N-vinyl-N-ethylacetamide, N-vinyl-N-ethylformamide, and mixtures thereof; (6) a methylene-containing pyrrolidone monomer selected from the group consisting of 1-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 1-n-propyl-3-methylene-2-pyrrolidone, 1-n-propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3-methylene-2-pyrrolidone, 1-isopropyl-5-methylene-2-pyrrolidone, 1-n-butyl-3-methylene-2-pyrrolidone, 1-tert-butyl-3-methylene-2-pyrrolidone, and combinations thereof;(7) an acrylic monomer having a C1-C4 alkoxyethoxy group and selected from the group consisting of ethylene glycol methyl ether (meth)acrylate, di(ethylene glycol) methyl ether (meth)acrylate, tri(ethylene glycol) methyl ether (meth)acrylate, tetra(ethylene glycol) methyl ether (meth)acrylate, C1-C4-alkoxy poly(ethylene glycol) (meth)acrylate having a number average molecular weight of up to 1500, methoxy-poly(ethylene glycol)ethyl (meth)acrylamide having a number average molecular weight of up to 1500, and combinations thereof; (8) A vinyl ether monomer selected from the group consisting of ethylene glycol monovinyl ether, di(ethylene glycol) monovinyl ether, tri(ethylene glycol) monovinyl ether, tetra(ethylene glycol) monovinyl ether, poly(ethylene glycol) monovinyl ether, ethylene glycol methyl vinyl ether, di(ethylene glycol) methyl vinyl ether, tri(ethylene glycol) methyl vinyl ether, tetra(ethylene glycol) methyl vinyl ether, poly(ethylene glycol) methyl vinyl ether, and combinations thereof; (9) an allyl ether monomer selected from the group consisting of ethylene glycol monoallyl ether, di(ethylene glycol) monoallyl ether, tri(ethylene glycol) monoallyl ether, tetra(ethylene glycol) monoallyl ether, poly(ethylene glycol) monoallyl ether, ethylene glycol methylallyl ether, di(ethylene glycol) methylallyl ether, tri(ethylene glycol) methylallyl ether, tetra(ethylene glycol) methylallyl ether, poly(ethylene glycol) methylallyl ether, and combinations thereof;(10) A vinyl monomer containing phosphocholine selected from the group consisting of: (meth)acryloyloxyethyl phosphocholine, (meth)acryloyloxypropyl phosphocholine, 4-((meth)acryloyloxy)butyl-2'-(trimethylammonio)ethyl phosphate, 2-[(meth)acryloylamino]ethyl-2'-(trimethylammonio)-ethyl phosphate, 3-[(meth)acryloylamino]propyl-2'-(trimethylammonio)ethyl phosphate, 4-[(meth)acryloylamino]butyl-2'-(trimethylammonio)ethyl phosphate -(trimethylammonio)ethyl phosphate, 5-((meth)acryloyloxy)pentyl-2'-(trimethylammonio)ethyl phosphate, 6-((meth)acryloyloxy)hexyl-2'-(trimethylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl-2'-(triethylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl-2'-(tripropylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl-2'-(tributylammonio)ethyl phosphate , 2-((meth)acryloyloxy)propyl-2'-(trimethylammonio)-ethyl phosphate, 2-((meth)acryloyloxy)butyl-2'-(trimethylammonio)ethyl phosphate, 2-((meth)acryloyloxy)pentyl-2'-(trimethylammonio)ethyl phosphate, 2-((meth)acryloyloxy)hexyl-2'-(trimethylammonio)ethyl phosphate, 2-(vinyloxy)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(allyloxy)ethyl-2'-( trimethylammonio)ethyl phosphate, 2-(vinyloxycarbonyl)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(allyloxycarbonyl)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(vinylcarbonylamino)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(allyloxycarbonylamino)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(butenyloxy)ethyl-2'-(trimethylammonio)ethyl phosphate, and combinations thereof; (11) allyl alcohol; (12) N-2-hydroxyethyl vinylcarbamate; (13) N-carboxyvinyl-β-alanine (VINAL); (14) N-carboxyvinyl-α-alanine; (15) or combinations thereof. ; 45. The method of any one of embodiments 36 to 43, wherein the at least one hydrophilic vinyl monomer comprises N-vinyl pyrrolidone, N-vinyl-N-methylacetamide, or a combination thereof. 46. ​​The method according to any one of embodiments 36 to 45, wherein the at least one hydrophilic vinyl monomer comprises at least one (meth)acrylamide monomer selected from the group consisting of: (meth)acrylamide, N,N-dimethyl(meth)acrylamide, N-ethyl(meth)acrylamide, N,N-diethyl(meth)acrylamide, N-propyl(meth)acrylamide, N-isopropyl(meth)acrylamide, N-3-methoxypropyl(meth)acrylamide, N-2-hydroxyethyl(meth)acrylamide, N,N-bis(hydroxyethyl)(meth)acrylamide, N-3-hydroxypropyl(meth)acrylamide, N-2-hydroxypropyl(meth)acrylamide, N-2,3-dihydroxypropyl(meth)acrylamide, N-Tris(hydroxymethyl)methyl(meth)acrylamide, 2-(meth)acrylamidoglycolic acid, 3-(meth)acrylamidopropionic acid, 5-(meth)acrylamidovaleric acid, 4-(meth)acrylamidobutyric acid, 3-(meth)acrylamido-2-methylbutyric acid, 3-(meth)acrylamido-3-methylbutyric acid, 2-(meth)acrylamido-2-methyl-3,3-dimethylbutyric acid, 3-(meth)acrylamidohexanoic acid, 4-(meth)acrylamido-3,3-dimethylhexanoic acid , N-2-aminoethyl(meth)acrylamide, N-2-methylaminoethyl(meth)acrylamide, N-2-ethylaminoethyl(meth)acrylamide, N-2-dimethylaminoethyl(meth)acrylamide, N-3-aminopropyl(meth)acrylamide, N-3-methylaminopropyl(meth)acrylamide, N-3-dimethylaminopropyl(meth)acrylamide, methoxy-poly(ethylene glycol)ethyl(meth)acrylamide having a number average molecular weight of up to 1500, and combinations thereof. 47. The method of any one of embodiments 36 to 45, wherein the at least one hydrophilic vinyl monomer comprises (meth)acrylamide, N,N-dimethyl(meth)acrylamide, N-ethyl(meth)acrylamide, N,N-diethyl(meth)acrylamide, N-propyl(meth)acrylamide, N-isopropyl(meth)acrylamide, N-3-methoxypropyl(meth)acrylamide, N-2-hydroxyethyl(meth)acrylamide, or a combination thereof. 48. The method of any one of embodiments 36 to 47, wherein the at least one hydrophilic vinyl monomer comprises 2-hydroxyethyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol) (meth)acrylate, tri(ethylene glycol) (meth)acrylate, tetra(ethylene glycol) (meth)acrylate, poly(ethylene glycol) (meth)acrylate having a number average molecular weight of up to 1500, or a combination thereof.49. The method of any one of embodiments 36 to 48, wherein the lens-forming composition comprises at least one polysiloxane vinyl monomer selected from the group consisting of: α-(meth)acryloyloxypropyl-terminated ω-C 1 -C 4-alkyl-terminated polydimethylsiloxane, α-(meth)acryloyloxy-2-hydroxypropoxypropyl-terminated ω-C 1 -C 4-alkyl-terminated polydimethylsiloxane, α-(2-hydroxy-methacryloyloxypropoxypropyl)-ω-C 1 -C 4-alkyl-decamethylpentasiloxane, α-[3-(meth)acryloyloxyethoxy-2-hydroxypropoxypropyl]-terminated ω-C 1 -C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acryloyloxy-propoxy-2-hydroxypropoxypropyl]-terminated ω-C 1 -C 4-alkyl- 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acryloyloxyisopropoxy-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acryloyloxybutoxy-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acryloyloxyethylamino-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acryloyloxypropylamino-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acryloyloxy-butylamino-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-(meth)acryloyloxy(polyethyleneoxy)-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropoxy-ethoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropyl-N-ethylaminopropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropyl-aminopropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropyloxy-(polyethyleneoxy)propyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-(meth)acrylamidopropoxypropyl-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-N-methyl-(meth)acrylamidopropoxypropyl-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamidoethoxy-2-hydroxypropoxy-propyl]-terminated ω-C 1-C4-alkyl polydimethylsiloxane, α-[3-(meth)acrylamidopropoxy-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamidoisopropoxy-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamidobutoxy-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamidobutoxy-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamido-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl polydimethylsiloxane, α-[3-[N-methyl-(meth)acrylamido]-2-hydroxypropoxypropyl]-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, N-methyl-N'-(propyltetra(dimethylsiloxy)dimethylbutylsilane)(meth)acrylamide, N-(2,3-dihydroxypropane)-N'-(propyltetra(dimethylsiloxy)dimethylbutylsilane)(meth)acrylamide, (meth)acrylamidopropyltetra(dimethylsiloxy)dimethylbutylsilane, α-vinyl carbonate-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, α-vinyl carbamate-terminated ω-C 1-C 4-alkyl-terminated polydimethylsiloxane, or a mixture thereof. 50. The method of any one of embodiments 36 to 49, wherein the lens-forming composition comprises at least one silicone-containing vinyl monomer selected from the group consisting of a vinyl monomer having a bis(trialkylsiloxy)alkylsilyl group, a vinyl monomer having a tri(trialkylsiloxy)silyl group, a polysiloxane vinyl monomer, 3-methacryloyloxypropyl pentamethyldisiloxane, tertiary butyldimethyl-siloxyethyl vinyl carbonate, trimethylsilylethyl vinyl carbonate, and trimethylsilylmethyl vinyl carbonate, and combinations thereof. 51. The method of any one of embodiments 36 to 49, wherein the lens-forming composition comprises at least one silicone-containing vinylic monomer having formula (M1) or (M2): Wherein: a M1 is zero or 1; R M0 is H or methyl; X M0 is O or NR M1; L M1 is a C 2-C 8 alkylene divalent group or a divalent group 、 、 、 、 、 or ; L M1' is a C 2 -C 8 alkylene divalent group having zero or one hydroxyl group; L M1" is a C 3 -C 8 alkylene divalent group having zero or one hydroxyl group; X M1 is O, NR M1, NHCOO, OCONH, CONR M1, or NR M1CO; R M1 is H or a C 1 -C 4 alkyl group having 0 to 2 hydroxyl groups; R t1 and R t2 are independently C 1 -C 6 alkyl groups; X M1' is O or NR 1; v1 is an integer from 1 to 30; m2 is an integer from 0 to 30; n1 is an integer from 3 to 40; and r1 is an integer from 2 or 3. 52. The method of any one of embodiments 36 to 51, wherein the lens-forming composition comprises tris(trimethylsiloxy)silylpropyl(meth)acrylate, [3-(meth)acryloyloxy-2-hydroxypropoxy]propylbis(trimethylsiloxy)methylsilane, [3-(meth)acryloyloxy-2-hydroxypropoxy]propylbis(trimethylsiloxy)butylsilane, 3-(meth)acryloyloxy-2-(2-hydroxyethoxy)-propoxy)propylbis(trimethylsiloxy)methylsilane, 3-(meth)acryloyloxy-2-hydroxypropoxy)propyltris(trimethylsiloxy) Methylsiloxy)silane, N-[tris(trimethylsiloxy)silylpropyl]-(meth)acrylamide, N-(2-hydroxy-3-(3-(bis(trimethylsiloxy)methylsilyl)propoxy)propyl)-2-methyl(meth)acrylamide, N-(2-hydroxy-3-(3-(bis(trimethylsiloxy)methylsilyl)propoxy)propyl)(meth)acrylamide, N-(2-hydroxy-3-(3-(tris(trimethylsiloxy)silyl)propoxy)propyl)-2-methylacrylamide, N-(2-hydroxy-3-(3-(tris(trimethylsiloxy)silyl)propoxy)propyl)-2-methylacrylamide, )silyl)propoxy)propyl)(meth)acrylamide, N-[tris(dimethylpropylsiloxy)silylpropyl]-(meth)acrylamide, N-[tris(dimethylphenylsiloxy)-silylpropyl](meth)acrylamide, N-[tris(dimethylethylsiloxy)-silylpropyl](meth)acrylamide, N,N-bis[2-hydroxy-3-(3-(bis(trimethylsiloxy)methylsilyl)-propoxy)propyl]-2-methyl(meth)acrylamide, N,N-bis[2-hydroxy-3-(3-(bis(trimethylsiloxy)methylsilyl)propoxy) -propyl] (meth) acrylamide, N,N-bis[2-hydroxy-3-(3-(tris(trimethylsilyloxy)silyl)-propoxy)propyl]-2-methyl(meth) acrylamide, N,N-bis[2-hydroxy-3-(3-(tris(trimethylsilyloxy)silyl)-propoxy)propyl] (meth) acrylamide, N-[2-hydroxy-3-(3-(tert-butyldimethylsilyl)propoxy)-propyl]-2-methyl(meth) acrylamide, N-[2-hydroxy-3-(3-(tert-butyldimethylsilyl)propoxy)-propyl] (meth) acrylamide, N,N-bis[2-hydroxy-3-(3-(tributyldimethylsilyl)propoxy)propyl]-2-methyl(meth)acrylamide, N-2-(meth)acryloxyethyl-O-(methyl-bis-trimethylsiloxy-3-propyl)silylcarbamate, 3-(trimethylsilyl)propylvinylcarbamate, 3-(vinyloxycarbonylthio)-propyl-tris(trimethylsiloxy)silane, 3-[tri(trimethylsiloxy)silyl]propylvinylcarbamate, 3-[tri(trimethylsiloxy)silyl]propylallylcarbamate, 3-[tri(trimethylsiloxy)silyl]propylvinyl carbonate, or a combination thereof. 53. The method of any one of embodiments 36 to 52, wherein the lens forming composition comprises at least one non-silicone vinyl crosslinker. 54. The method of embodiment 53, wherein the at least one non-silicone vinyl crosslinking agent comprises ethylene glycol di-(meth)acrylate, diethylene glycol di-(meth)acrylate, triethylene glycol di-(meth)acrylate, tetraethylene glycol di-(meth)acrylate, glycerol di-(meth)acrylate, 1,3-propylene glycol di-(meth)acrylate, 1,3-butylene glycol di-(meth)acrylate, 1,4-butylene glycol di-(meth)acrylate, acrylate, glyceryl 1,3-diglycerate di-(meth)acrylate, ethylidene bis[oxy(2-hydroxypropane-1,3-diyl)] di-(meth)acrylate, bis[2-(meth)acryloyloxyethyl] phosphate, trimethylolpropane di-(meth)acrylate, and 3,4-bis[(meth)acryloyl]tetrahydrofuran, diacrylamide, dimethylacrylamide, N,N-di(meth)acryloyl-N-methylamine, N,N -Di(meth)acryl-N-ethylamine, N,N'-methylenebis(meth)acrylamide, N,N'-ethylenebis(meth)acrylamide, N,N'-dihydroxyethylenebis(meth)acrylamide, N,N'-propylenebis(meth)acrylamide, N,N'-2-hydroxypropylenebis(meth)acrylamide, N,N'-2,3-dihydroxybutylenebis(meth)acrylamide, 1,3-bis(meth)acrylamide propane- 2-aminobenzoic acid ester, ... 55. The method of any one of embodiments 36 to 54, wherein the lens forming composition comprises at least one blended vinyl monomer. 56. The method of embodiment 55, wherein the at least one blended vinyl monomer comprises C1-C10 alkyl (meth)acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tertiary butylstyrene (TBS), trifluoroethyl (meth)acrylate, hexafluoroisopropyl (meth)acrylate, hexafluorobutyl (meth)acrylate, or a combination thereof. 57. The method of any one of embodiments 36 to 56, wherein the first and second lens-forming compositions comprise at least one polymerizable material selected from the group consisting of UV-absorbing vinylic monomers, UV / HEVL-absorbing vinylic monomers, photochromic vinylic monomers, polymerizable dyes, and combinations thereof. 58. The method of any one of embodiments 36 to 57, wherein the bulk hydrogel material is a silicone hydrogel material having an equilibrium water content (i.e., in a fully hydrated state or when fully hydrated) of from about 20% to about 70% by weight, an oxygen permeability of at least about 40 barrers, and a modulus (i.e., Young's modulus) of from about 0.2 MPa to about 1.5 MPa.

[0148] The above disclosure will enable those skilled in the art to practice the present invention. Various modifications, variations, and combinations of the various embodiments described herein are possible. To better understand the specific embodiments and advantages thereof, reference is made to the following examples. It is intended that this description and examples be considered illustrative. [Example] [1] [Oxygen permeability measurement] []

[0149] Unless otherwise specified, determine the oxygen transmissibility (Dk / t), intrinsic (or edge-corrected) oxygen transmissibility (Dk i or Dk c) of lenses and lens materials according to the procedures described in ISO 18369-4. [Balanced moisture content]

[0150] The equilibrium water content (EWC) of contact lenses is determined as follows.

[0151] The amount of water (expressed as weight percent) present in a fully hydrated hydrogel contact lens equilibrated in saline solution at room temperature is determined. After blotting the lenses with a cloth, quickly stack the lenses and transfer the lens stack to an aluminum pan on an analytical balance. The number of lenses used for each sample pan is typically five (5). Record the hydrated weight of the pan plus the lenses. Cover the pan with aluminum foil. Place the pan in a laboratory oven at 100°C ± 2°C and dry for 16-18 hours. Remove the pan plus lenses from the oven and cool in a desiccator for at least 30 minutes. Remove the individual pans from the desiccator and remove the aluminum foil. Weigh the pan plus the dried lens sample on an analytical balance. Repeat for all pans. The wet and dry weights of the lens sample can be calculated by subtracting the weight of the empty weighing pan. [Elastic modulus]

[0152] The storage modulus (Young's modulus) of the inserts was determined using a TA RSA-G2 DMA (Dynamic Mechanical Analyzer). The inserts were cut into 3.08 mm wide strips using a Precision Concept dry lens cutter. Five thickness values ​​were measured over a 6.5 mm gauge length. The strips were mounted on the instrument with metal clamps. An oscillatory temperature ramp test from 10°C to 50°C was applied to the inserts at a linear ramp rate of 2°C / minute. The material's response to the temperature increase was monitored at a constant frequency of 1 Hz, a constant amplitude of 0.5% deformation, and a sampling rate of 10.0 pts / s. Storage modulus (E'), loss modulus (E''), and tan δ data were calculated using TRIOS software.

[0153] The elastic modulus of silicone hydrogel materials or contact lenses is measured using an MTS insight instrument. First, the contact lenses are cut into 3.12 mm wide strips using a Precision Concept two-stage cutter. Five thickness values ​​are measured over a 6.5 mm gauge length. The strip is mounted in the instrument holder and immersed in PBS (phosphate-buffered saline) at a controlled temperature of 21°C ± 2°C. Testing is typically performed using a 5N load cell. A constant force and velocity are applied to the sample until it breaks. Force and displacement data are collected using TestWorks software. The elastic modulus value is calculated using TestWorks software as the slope or tangent of the stress vs. strain curve near zero elongation in the elastic deformation region. [Layering]

[0154] Inspect embedded hydrogel contact lenses for possible delamination using an Optimec instrument or optical coherence tomography (OCT).

[0155] Regardless of the evaluation method, contact lenses were staged at room temperature for a minimum of 12 hours after the autoclave run and prior to the delamination studies.

[0156] After the required grading time, fully hydrated contact lenses were placed in the "V" grid assembly of the Optimec instrument (Model JCF; OPTIMEC, UK). After securing the contact lenses under gravity, the front view of the contact lenses was carefully examined for any signs of circular patterns. Delamination appears as a circular pattern in the Optimec image.

[0157] OCT (spectral-domain optical coherence tomography; Telesto-II; Thorlabs) can also be used to study delamination. OCT allows non-invasive imaging of contact lenses to obtain high-resolution cross-sectional images. To this end, after meeting minimum staging requirements, the contact lens is removed from its blister and soaked in a PBS solution for a minimum of 30 minutes to equilibrate. A cuvette with a "V"-shaped block feature is then approximately ¾ filled with fresh PBS solution, and the contact lens is transferred to the cuvette using Q-tips. The lens is allowed to float freely into the "V" at the bottom of the cuvette, and the entire contact lens is scanned in 10-degree increments. In OCT images, delamination appears as air pockets on the spacer surfaces of the insert and carrier. [Chemicals] []

[0158] The following abbreviations are used in the following examples: PEMA, phenylethyl methacrylate; D6, monobutyl-terminated monomethacryloxypropyl-terminated polydimethylsiloxane (Mn approximately 700-800 g / mol, from Shin-Etsu); BDDA, 1,4-butanediol diacrylate; DtBN, di- and tertiary butyl nitroxides; VAZO 64, 2,2′-azobis(isobutyronitrile); TrisMA, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate; DMA, N,N-dimethylacrylamide; MMA, methyl methacrylate; Betacon, dimethacrylate-terminated chain-extended polydimethylsiloxane (Mn approximately 5000 g / mol), having two PDMS segments separated by a perfluoropolyether (PFPE) via a diurethane linkage between polydimethylsiloxane (PDMS) and PFPE and two urethane linkages, each between a terminal methacrylate group and a PDMS segment, prepared according to a method similar to the method described in Example B-1 of US Pat. No. 5,760,100; EGBE denotes ethylene glycol butyl ether; PBS denotes phosphate-buffered saline having a pH of 7.2 ± 0.2 at 25° C. and containing approximately 0.044 wt.% NaH 2PO 4·H 2O, approximately 0.388 wt.% Na 2HPO 4·2H 2O, and approximately 0.79 wt.% NaCl; and wt.% denotes weight percentage. [Example] [2] [Insert] []

[0159] The rigid hydrophobic insert was prepared by hot casting molding of the insert forming composition shown in Table 1. [Table 1] Insert forming composition PEMA D6 BDDA Vazo 64 DtB I1-1 62 27 10 1 I1-2 62 27 10 1 0.5

[0160] The insert-forming composition was purged with nitrogen at room temperature for 30 to 35 minutes. A quantity of the N2-purged insert-forming composition was placed at the center of the molding surface of a female insert mold half made of polypropylene. The female insert mold half containing the insert-forming composition was sealed with a male insert mold half made of polypropylene. The oven was configured as follows: a nitrogen supply was connected to the oven via a high-flow controller that controlled the flow rate of nitrogen through the oven; a vacuum pump was connected to the oven exhaust line to control the pressure differential within the oven.

[0161] The insert-forming composition in the insert mold is thermally cured in an oven under the following conditions: ramping from room temperature to 55°C at a ramp rate of about 7°C / min; holding at 55°C for about 30-40 minutes; ramping from 55°C to 80°C at a ramp rate of about 7°C / min; holding at 55°C for about 30-40 minutes; ramping from 80°C to 100°C at a ramp rate of about 7°C / min; and holding at 100°C for about 30-40 minutes. The insert mold is opened and the molded insert is removed from the mold half to which the insert is adhered.

[0162] The resulting insert had a diameter (from edge to edge of the insert) of approximately 8.0 mm. [Lens forming composition] []

[0163] A lens-forming composition (i.e., a SiHy lens formulation) was prepared by blending all components (materials) at room temperature in air to have the following composition: Betacon (29 unit parts by weight); TrisMA (17 unit parts by weight); DMA (28 unit parts by weight); EGBE (25 unit parts by weight); and Vazo 64 (0.5 unit parts by weight). [Preparation of embedded silicone hydrogel contact lenses] []

[0164] Using an insert precision placement tool (or any other known method to those skilled in the art), the 8.0 mm diameter insert prepared above is precisely placed in the center of the female lens mold half (with guide pins). A quantity of lens-forming composition is introduced into the female lens mold half to completely immerse the insert. The male lens mold half is placed on top of the female lens mold half and then closed to form a molded assembly including the insert immersed in the lens-forming composition. The lens-forming composition in the molded assembly is actinically cured using a mercury-lamp-based UV box at an intensity of approximately 3 mW / cm² for 5-10 minutes to form an embedded hydrogel lens precursor. The molded assembly is opened and the molded embedded hydrogel lens precursor is removed from the lens mold.

[0165] Each lens mold having a molded silicone hydrogel lens precursor therein is mechanically opened. The molded embedded silicone hydrogel lens precursor is adhered to either the male lens mold half or the female lens mold half. The molded embedded silicone hydrogel lens precursor adhered to the male lens mold half is delensed using an ultrasonic wave unit; the molded embedded silicone hydrogel lens precursor adhered to the female lens mold half is manually delensed from the female lens mold half to which the lens is adhered.

[0166] The delensed, embedded silicone hydrogel lens precursor can be extracted with a 50:50 mixture of propylene glycol and water. Preferably, the delensed, embedded silicone hydrogel lens precursor is subjected to the following extraction / hydration, coating, and autoclaving processes: soaking the embedded silicone hydrogel lens precursor in a bath containing deionized water or a 500 PPM Tween 80 aqueous solution for approximately 60 minutes, then soaking it in a bath containing an aqueous solution of polyacrylic acid (PAA, Mw 450K) at a concentration of approximately 0.1% by weight at 40°C for approximately 120 minutes; then soaking it in a bath containing a PBS solution at room temperature for approximately 60 minutes; packaging / sealing it in polypropylene lens packaging shells (or blisters) (one lens per shell) with 0.65 mL of packaging saline prepared according to the procedure described in Example 19 of US Pat. No. 8,480,227; and finally autoclaving it at 121°C for approximately 45 minutes. The resulting embedded SiHy contact lenses each had a hydrogel coating thereon.

[0167] The resulting embedded SiHy contact lens was inspected for delamination according to the procedure described in Example 1. When the insert was prepared from the insert-forming composition I1-2 containing an iniferter (DtBN), no bubbles were observed at the interface between the insert (I1-2) and the SiHy bulk material within the embedded silicone hydrogel contact lens under a microscope, indicating no delamination. When the insert was prepared from the insert-forming composition I1-1 not containing an iniferter (DtBN), numerous bubbles were observed at the interface between the insert (I1-1) and the SiHy bulk material within the embedded silicone hydrogel contact lens under a microscope, indicating delamination.

[0168] All publications, patents, and patent application publications cited above in this application are hereby incorporated by reference in their entirety.

[0169] none

[0170] none

Claims

1. A method for producing an embedded hydrogel contact lens, the method comprising the steps of: (1) obtaining an insert mold, wherein the insert mold includes a male insert half having a first molding surface and a female insert half having a second molding surface, the male insert half and the female insert half being configured to receive each other such that when the female insert half is closed with the male insert half, an insert molding cavity is formed between the first molding surface and the second molding surface; (2) dispensing an insert forming composition into the female insert half, wherein the insert forming composition comprises (i) at least one polymerizable material, (ii) at least one first free radical initiator, and (iii) at least one initiation transfer terminator; (3) closing the female insert half with the male insert half to form a first molding assembly, the first molding assembly including the insert forming composition within the insert molding cavity of the insert mold; (4) The insert forming composition is thermosetting or photosetting in the insert molding cavity of the first molding assembly to form a molded insert made of a first crosslinked polymer material, the first crosslinked polymer material comprising an initiator transfer terminator portion covalently attached thereto; (5) obtaining a lens mold and a lens forming composition, wherein the lens mold comprises a male lens half mold having a third molding surface and a female lens half mold having a fourth molding surface, the male lens half mold and the female lens half mold being configured to receive each other such that when the female lens half mold is closed with the male lens half mold, a lens molding cavity is formed between the third molding surface and the fourth molding surface, wherein the lens forming composition comprises at least one second polymerizable material and a second free radical initiator; (6) without a specific order, the insert obtained in step (4) is placed at a desired position in the female lens half mold and the lens forming composition is dispensed into the female lens half mold, wherein the insert is immersed in the lens forming composition; (7) (7) The negative lens half mold and the positive lens half mold are closed to form a second molding assembly, the second molding assembly including the lens forming composition in the lens molding cavity of the lens mold and the insert immersed therein; (8) The lens forming composition is thermo-cured or photo-cured in the lens molding cavity of the second molding assembly, while initiating transfer terminator-induced polymerization of the lens forming composition at and near the surface of the insert to form an embedded hydrogel lens precursor, the embedded hydrogel lens precursor including a bulk hydrogel material formed by the lens forming composition and the insert embedded in the bulk material, wherein the bulk hydrogel material is a second crosslinked polymer material, the second crosslinked polymer material being covalently connected to the first crosslinked polymer material at the initiation transfer terminator portion located at and near the surface of the insert;(9) Separate the lens mold obtained in step (8) into the positive lens half-mold and the negative lens half-mold, wherein the embedded hydrogel lens precursor is adhered to the lens half-mold to which the lens is adhered, and the lens half-mold to which the lens is adhered is one of the positive lens half-mold and the negative lens half-mold; (10) Remove the embedded hydrogel lens precursor from the lens half-mold to which the lens is adhered; and (11) subject the embedded hydrogel lens precursor to a molding post-process to form the embedded hydrogel contact lens, the process including a hydration process and one or more other processes selected from the group consisting of: extraction, surface treatment, packaging, sterilization, and combinations thereof.

2. The method as described in claim 1, wherein, The at least one initiating transfer terminator includes a compound containing a thiocarbonyl group having a thiocarbonyl thio group moiety.

3. The method as described in claim 2, wherein, The at least one thiocarbonyl thio group is a dithioester, a dithioaminocarbamate, a dithioester, a trithiocarbonate, a xanthate, a thiuram monosulfide, a thiuram disulfide, a xanthate disulfide, or a combination thereof.

4. The method as described in claim 1, wherein, The at least one initiating transfer terminator comprises at least one thiocarbonyl thio group-containing compound selected from the group consisting of: thiuram monosulfide, N,N'-dimethylthiuram monosulfide, N,N,N',N'-tetramethylthiuram monosulfide, N,N'-diethylthiuram monosulfide, N,N,N',N'-tetraethylthiuram monosulfide, thiuram disulfide, N,N-dimethyl Thiuram disulfide, N,N'-diethylthiuram disulfide, N,N'-diethyl-N,N'-bis(2-hydroxyethyl)thiuram disulfide, N,N'-bis(N-(2-phthaliminoethyl)piperazine-thiuram disulfide, N,N'-dimethylthiuram tetrasulfide, tetramethylthiuram disulfide, tetraethylthiuram disulfide, tetraisopropylthiuram disulfide, N,N′-dimethylN,N′-di(4-pyridyl)thiuram disulfide, bis(thiobenzoyl) disulfide, diisopropyl xanthate disulfide, cyanomethyl dithiobenzoate, benzyl dithiobenzoate, 2-phenyl-2-propyl dithiobenzoate, bis(thiobenzoyl) disulfide, 1 H-pyrrole-1-dithiocarbamate benzyl ester, 2-cyano-2-propyl dithiobenzoate, bis(carboxymethyl)trithiocarbonate, 4-cyano-4-(thiobenzoylthio)valerate, ethyl 2-(phenylthiocarbonylthio)-2-phenylacetate, ethyl 2-(phenylthiocarbonylthio)propionate, 1-(methoxycarbonyl)ethyl dithiobenzoate, 2-cyano-2-propyl 4-cyanodithiobenzoate, 2-(4-methoxy) Ethyl phenylthiocarbonylthio)acetate, ethyl 2-methyl-2-(phenylthio-carbonylthio)propionate, ethyl 2-(phenylthiocarbonylthio)-2-phenylacetate, 2-(4-methoxy-phenylthiocarbonylthio)acetic acid, 2-nitro-5-(2-propynyloxy)benzyl 4-cyano-4-(phenyl-thiocarbonylthio)valerate, S,S-bis(α,α′-dimethyl-α″-acetic acid)trithiocarbonate, S-dodecyl-S′ -(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, S-ethyl-S′-(α,α′-dimethyl-α″-acetic acid) trithiocarbonate, 4-cyano-4-ethyl-trithiovalerate, S,S-dibenzyl trithiocarbonate, bis(carboxymethyl) trithiocarbonate, dimethyl trithiocarbonate, phthalimino-methylbutyl trithiocarbonate, cyanomethyl dodecyl trithiocarbonate, 4-cyano-4-[( Dodecyl-hydrothiocarbonyl)hydrothio]valeric acid, 3,5-bis(2-dodecylthiothiocarbonylthio-1-sideoxypropoxy)benzoic acid, 2-(2-carboxyethylhydrothiothiocarbonylhydrothio)propionic acid, 2-cyano-2-propyldodecyl trithiocarbonate, 2-(dodecylthiothiocarbonylthio)-2-methylpropionic acid 3-butenyl ester, 2-(dodecylthiothiocarbonylthio)-2-methylpropionic acid, (3,5-Dimethyl-1H-pyrazole)-dithiocarbamate cyanomethyl ester, 2-cyanobutyl-2-yl4-chloro-3,5-dimethyl-1H-pyrazole-1-dithiocarbamate, 2-[methyl(4-pyridyl)thioaminomethylthio]propionate methyl ester, 2-cyanobutyl-2-yl3,5-dimethyl-1H-pyrazole-1-dithiocarbamate, cyanomethylmethyl(phenyl)dithiocarbamate, cyanomethylmethyl(4-pyridyl)dithiocarbamate, 1 H-pyrrole-1-dithiocarbamate benzyl ester, cyanomethyl diphenyl dithiocarbamate, cyanomethyl methyl (4-pyridyl) dithiocarbamate, benzyl-N,N-dimethyl dithiocarbamate, benzyl-N,N-diethyl dithiocarbamate, 2-(N,N-diethyldithiocarbamate)isobutyric acid, ethyl 2-(N,N-diethyldithiocarbamate)isobutyrate, (4-cyano-4-di ... Ethyl dithioaminomethyl)valeric acid, 1-(ethoxy-carbonyl)prop-1-yl dithiobenzoate, benzoyl methyl phosphono-4-dithioaminocarboxylate, S-2-cyano-2-propyl-O-ethyl xanthate, 1-phenylethylphenyl dithioacetic acid ester, S-methacrylic acid-O-ethyl xanthate, 2-(N,N-diethyldithioaminomethyl)ethyl methacrylate, 2-(N,N-diethyldithioaminomethyl)ethyl methacrylate, acetic acid 2-(N,N-diethyldithioaminomethyl)ethyl methacrylate Ethyl dithioaminomethyl)ethyl ether, cyanopentarate dithiobenzoate, 3-benzylhydrothiocarbonyl-hydrothiopropionic acid, 2-(n-butyl trithiocarbonate)-propionic acid, N,N-dimethyl-dithioaminocarbamate n-butyl ester, benzyl dithioaminocarbamate, p-xylene-bis(dithioaminocarbamate), p-xylene-bis(N,N-dimethyldithioaminocarbamate), p-xylene-bis(N,N-diethyl) Dithiocarbamates, 1,2-bis(N,N-diethyldithiocarbamate), 1,2-bis(N,N-dimethyldithiocarbamate), 1,2,3-tris(N,N-dimethyldithiocarbamate), 1,2,4,5-tetra(N,N-diethyldithiocarbamate), 1-(N,N-diethyldithiocarbamate)ethyl acetate, and combinations thereof.

5. The method as described in claim 1, wherein, The at least one initiating transfer terminator comprises at least one organic nitrogen oxide compound.

6. The method as described in claim 5, wherein, The at least one organic nitrogen oxide compound is selected from the group consisting of: ((2',2',6',6'-tetramethyl-1'-piperidinoxy)methyl)benzene, 1-phenyl-1-(2',2',6',6'-tetramethyl-1'-piperidinoxy)ethane, 1-(4'-bromophenyl)-1-(2",2",6",6"-tetramethyl-1"-piperidinoxy)ethane, 1-naphthyl-1-(2',2',6',6'-tetramethyl-1'-piperidinoxy)ethane, 1-phenyl-1-(2',2',6',6'-tetramethyl-1'-piperidinoxy)ethane, 1-phenyl-1-(2',2',6',6'-tetramethyl-1'-piperidinoxy)ethane, etc. Methyl-1-piperidinoxy)propane, 1-(benzyloxy)-2-phenyl-2-(2',2',6',6'-tetramethyl-1'-piperidinoxy)ethane, 1-hydroxy-2-phenyl-2-(2',2',6',6'-tetramethyl-1-piperidinoxy)ethane, 4-cyano-4-(2',2',6',6'-tetramethyl-1'-piperidinoxy)phenyl valerate, 4-cyano-4-(2',2',6',6'-tetramethyl-1'-piperidinoxy)pentafluorophenyl valerate, 3-phenyl-1-(2',2',6',6'-tetramethyl-1'-piperidinoxy)valerate ',6'-Tetramethyl-1'-piperidinyloxy)propane, 1-((2',2',6',6'-Tetramethyl-1'-piperidinyloxy)methyl)-4-(trifluoromethyl)benzene, 2-((4-benzoylphenyl)((1-methoxy-2-methyl-1-t-oxypropyl-2-yl)oxy)amino)-2-methylpropionate methyl ester, 2,2,6,6-Tetramethyl-1-piperidinyloxy, 2,2,5-trimethyl-4-phenyl-3-azahexane-3-oxyoxide, N-tert-butyl-N-1-phenyl-2-methylpropyl-oxyoxide, N- Tri-butyl-N-1-(2-naphthyl)-2-methyl-propyl nitride, N-tri-butyl-N-1-diethylphosphoni-2,2-dimethylpropyl nitride, N-tri-butyl-N-1-dibenzylphosphoni-2,2-dimethylpropyl nitride, N-phenyl-N-1-diethylphosphoni-2,2-dimethylpropyl nitride, N-phenyl-N-1-diethylphosphoni-1-methylethyl nitride, N-(1-phenyl-2-methylpropyl)-N-1-diethylphosphoni-1-methylethyl nitride, and combinations thereof.

7. The method as described in any one of claims 1 to 6, wherein, The insert forming composition comprises (a) the at least one first polymerizable material comprising at least one polymerizable photochromic compound (i.e., a photochromic vinyl monomer), at least one UV-absorbing vinyl monomer, at least one UV / HEVL-absorbing vinyl monomer, at least one fluorescent vinyl monomer, or a combination thereof, and / or (b) at least one color filter material, diffractive material, high refractive index material, or a combination thereof for correcting color blindness. The insert forms a compositional system comprising: a first polymerizable composition for forming crosslinked polymethyl methacrylate, the crosslinked polymethyl methacrylate comprising repeating units of methyl methacrylate and at least one vinyl crosslinking agent; a second polymerizable composition for forming a crosslinked silicone polymer having a three-dimensional polymer network, being insoluble in water, and having an equilibrium water content of about 5% or less by weight; a third polymerizable composition for forming a rigid, breathable material; or a fourth polymerizable composition for forming a hydrophobic crosslinked acrylic material having an equilibrium water content of less than 5% by weight and comprising, relative to the total amount of the at least one first polymerizable material and other polymerizable materials, at least 55% by moles of one or more acrylic monomers and / or one or more acrylic crosslinking agents, and at least about 6% by moles of at least one acrylic crosslinking agent and, if desired, at least one vinyl crosslinking agent other than an acrylic crosslinking agent.

8. The method as described in claim 7, wherein, The insert forming composition is the fourth polymerizable composition, wherein the at least one acrylic crosslinking agent in the fourth polymerizable composition is ethylene glycol dimethacrylate; ethylene glycol diacrylate; 1,3-propanediol diacrylate; 1,3-propanediol dimethacrylate; 2,3-propanediol diacrylate; 2,3-propanediol dimethacrylate; 1,4-butanediol dimethacrylate; 1,4-butanediol diacrylate; 1,5-pentanediol dimethacrylate; 1,5-pentanediol diacrylate; 1,6-hexanediol dimethacrylate; 1,6-hexanediol diacrylate; diethylene glycol dimethacrylate; diethylene glycol diacrylate; triethylene glycol dimethacrylate; triethylene glycol diacrylate; tetraethylene glycol dimethacrylate; tetraethylene glycol diacrylate; N,N'-methylenebis(propylene) N,N'-Methylenebis(methacrylamide); N,N'-Ethylenebis(acrylamide); N,N'-Ethylenebis(methacrylamide); N,N'-Hexamethylenebisacrylamide; N,N'-Hexamethylenebis(methacrylamide); Neopentyltetrol triacrylate, Neopentyltetrol trimethacrylate, Trimethylolpropane triacrylate, Trimethylolpropane trimethacrylate, Tri(2-hydroxyethyl) Tri(2-hydroxyethyl) isocyanurate triacrylate, tri(2-hydroxyethyl) isocyanurate trimethacrylate, 1,3,5-tripropenyloxyhexahydro-1,3,5-trimethuron, 1,3,5-trimethylpropenyloxyhexahydro-1,3,5-trimethuron; neopentyltetraacrylate, neopentyltetramethacrylate, di(trimethylolpropane)tetraacrylate, di(trimethylolpropane)tetramethacrylate, or combinations thereof.

9. The method as described in claim 7, wherein, The insert forms a composition that is the fourth polymerizable composition, wherein the at least one ethylene crosslinking agent in the fourth polymerizable composition includes divinylbenzene, 2-methyl-1,4-divinylbenzene, bis(4-vinylphenyl)methane, 1,2-bis(4-vinylphenyl)ethane, or combinations thereof.

10. The method as described in claim 7, wherein, The at least one first polymerizable material in the fourth polymerizable composition comprises: at least one silicone-containing acrylic monomer; at least one fluorinated acrylic monomer; at least one polysiloxane vinyl crosslinking agent; at least one aryl acrylic monomer; at least one hydrophobic vinyl monomer selected from the group consisting of: vinyl alkyl esters, vinyloxyalkanes, styrene, vinyltoluene, vinyl chloride, vinylidene chloride, 1-butene, and combinations thereof; or combinations thereof.

11. The method as described in claim 7, wherein, The lens forming composition comprises at least 50% by mole of at least one hydroxyl-containing vinyl monomer selected from the group consisting of: hydroxyethyl methacrylate, glycerol methacrylate, 3-hydroxypropyl methacrylate, 2-hydroxypropyl methacrylate, 3-amino-2-hydroxypropyl methacrylate, N-2-hydroxyethyl (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris(hydroxymethyl)methyl (meth)acrylamide, vinyl alcohol, allyl alcohol, and combinations thereof.

12. The method as described in claim 7, wherein, The lens forming composition comprises (a) at least one polysiloxane ethylene monomer and / or at least one first polysiloxane ethylene crosslinking agent and (b) at least one hydrophilic ethylene monomer.

13. The method as described in claim 12, wherein, The lens forming composition comprises at least one hydrophilic polysiloxane ethylene crosslinking agent, which comprises hydrophilic siloxane units, each having a methyl substituent and an organic group including at least one H bond donor.

14. The method as described in claim 12, wherein, The lens forming composition comprises: (1) an ethylene crosslinking agent comprising a single polydiorganosiloxane segment and two terminal olefinic unsaturated groups selected from the group consisting of (meth)acryloxy, (meth)acrylamide, vinyl carbonate, and vinylcarbamate; (2) an extended polysiloxane ethylene crosslinking agent comprising at least two polydiorganosiloxane segments and a covalent linker between each pair of polydiorganosiloxane segments and two terminal olefinic unsaturated groups selected from the group consisting of (meth)acryloxy, (meth)acrylamide, vinyl carbonate, and vinylcarbamate; (3)Polysiloxane-ethylene crosslinking agents, including: α,ω-bis[3-(meth)acrylamidepropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxyethoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxypropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, and α,ω-bis[3-(meth)acryloxy-isopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane. α,ω-bis[3-(meth)propenylaminobutoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)propenylaminoethoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)propenylaminopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)propenylaminoisopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)propenylaminobutoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)propenylaminoethylamino-2-hydroxypropoxypropyl] -Terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxypropylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxybutylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acrylaminoethylamino-2-hydroxy-propoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylaminopropyl-amino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamino-butylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloxy- 2-Hydroxypropoxy-ethoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloxy-2-hydroxypropyl-N-ethylaminopropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloxy-2-hydroxypropyl-aminopropyl]-polydimethylsiloxane, α,ω-bis[(meth)acryloxy-2-hydroxypropoxy-(polyvinyloxy)propyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloxyethylamino-carbonyloxy-ethoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloxyethylamino-carbonyloxy-(polyvinyloxy)propyl]-terminated polydimethylsiloxane, or combinations thereof; (4)At least one polysiloxane vinyl monomer selected from the group consisting of: α-(meth)propenyloxypropyl-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-(meth)propenyloxy-2-hydroxypropoxypropyl-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-(2-hydroxy-methpropenyloxypropoxypropyl)-ω-C1-C4-alkyl-decamethylpentasiloxane, α-[3-(meth)propenyloxyethoxy-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)propenyloxy-prop ... 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)propenyloxyisopropoxy-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)propenyloxybutoxy-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)propenyloxyethylamino-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)propenyloxypropyl ... 4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acryloxy-butylamino-2-hydroxypropoxy-propyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloxy-(polyvinyloxy)-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloxy-2-hydroxypropoxy-ethoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloxy-2-hydroxypropoxy-N-ethylaminopropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, 4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloxy-2-hydroxypropyl-aminopropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[(meth)acryloxy-2-hydroxypropoxy-(polyvinyloxy)propyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-(meth)acrylamino-propoxypropyl-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-N-methyl-(meth)acrylaminopropoxypropyl-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylaminoethoxy-2-hydroxypropoxy-propyl] ... 4-alkyl polydimethylsiloxane, α-[3-(meth)propenylaminopropoxy-2-hydroxypropoxy-propyl]-terminated ω-C 1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamino-isopropoxy-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamino-butoxy-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxane, α-[3-(meth)acrylamino-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl polydimethylsiloxane, α-[3-[N-methyl-(meth)acrylamino]-2-hydroxypropoxypropyl]-terminated ω-C1-C4-alkyl 4-alkyl-terminated polydimethylsiloxanes, N-methyl-N'-(propyltetra(dimethylsiloxy)dimethylbutylsilane)(meth)acrylamide, N-(2,3-dihydroxypropane)-N'-(propyltetra(dimethylsiloxy)dimethyl-butylsilane)(meth)acrylamide, (meth)acrylamide-propyltetra(dimethylsiloxy)dimethyl-butylsilane, α-vinyl carbonate-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxanes, α-vinylaminocarbamate-terminated ω-C1-C4-alkyl-terminated polydimethylsiloxanes, or mixtures thereof; (5) At least one siloxane-containing vinyl monomer selected from the group consisting of: vinyl monomers having bis(trialkylsiloxy)alkylsilyl groups, vinyl monomers having tri(trialkylsiloxy)silyl groups, polysiloxane vinyl monomers, 3-methacryloxypropylpentamethyldisiloxane, tributyldimethyl-silalkoxyethyl vinyl carbonate, trimethylsilylethyl vinyl carbonate, and trimethylsilylmethyl vinyl carbonate, and combinations thereof; or (6) combinations thereof, wherein the at least one hydrophilic vinyl monomer comprises: (1) Alkyl (meth)acrylamides selected from the group consisting of: (meth)acrylamide, N,N-dimethyl (meth)acrylamide, N-ethyl (meth)acrylamide, N,N-diethyl (meth)acrylamide, N-propyl (meth)acrylamide, N-isopropyl (meth)acrylamide, N-3-methoxypropyl (meth)acrylamide, and combinations thereof; (2) Hydroxyl-containing acrylic monomers selected from the group consisting of: N-2-hydroxyethyl (meth)acrylamide, N,N-bis(hydroxyethyl) (meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide,N-tris(hydroxymethyl)methacrylamide, 2-hydroxyethyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, glyceryl methacrylate (GMA), di(ethylene glycol)(meth)acrylate, tri(ethylene glycol)(meth)acrylate, tetra(ethylene glycol)(meth)acrylate, poly(ethylene glycol)(meth)acrylate having a number average molecular weight of up to 1500, poly(ethylene glycol)ethyl(meth)acrylamide having a number average molecular weight of up to 1500, and combinations thereof; (3) The following are carboxyl-containing acrylic monomers selected from the group consisting of: 2-(meth)propenylaminoglycolic acid, (meth)acrylic acid, ethylacrylic acid, 3-(meth)propenylaminopropionic acid, 5-(meth)propenylaminovaleric acid, 4-(meth)propenylaminobutyric acid, 3-(meth)propenylamino-2-methylbutyric acid, 3-(meth)propenylamino-3-methylbutyric acid, 2-(meth)propenylamino-2-methyl-3,3-dimethylbutyric acid, 3-(meth)propenylaminohexanoic acid, 4-(meth)propenylamino-3,3-dimethylhexanoic acid, and combinations thereof; (4) Amine-containing acrylic monomers selected from the following group of compositions: N-2-aminoethyl (meth)acrylamide, N-2-methylaminoethyl (meth)acrylamide, N-2-ethylaminoethyl (meth)acrylamide, N-2-dimethylaminoethyl (meth)acrylamide, N-3-aminopropyl (meth)acrylamide, N-3-methylaminopropyl (meth)acrylamide, N-3-dimethylaminopropyl (meth)acrylamide, 2-Aminoethyl (meth)acrylate, 2-methylaminoethyl (meth)acrylate, 2-ethylaminoethyl (meth)acrylate, 3-aminopropyl (meth)acrylate, 3-methylaminopropyl (meth)acrylate, 3-ethylaminopropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, 2-hydroxypropyl(meth)acrylate trimethylammonium hydrochloride, dimethylaminoethyl (meth)acrylate, and combinations thereof; (5)N-vinylpyridine monomers selected from the group consisting of: N-vinylpyrrolidone, N-vinyl-3-methyl-2-pyrrolidone, N-vinyl-4-methyl-2-pyrrolidone, N-vinyl-5-methyl-2-pyrrolidone, N-vinyl-6-methyl-2-pyrrolidone, N-vinyl-3-ethyl-2-pyrrolidone, N-vinyl-4,5-dimethyl-2-pyrrolidone, N-vinyl-5,5-dimethyl-2-pyrrolidone, N-vinyl-3,3,5-trimethyl-2-pyrrolidone, N-vinylpiperidone, N-vinyl-3-methyl-2-piperidone, N-vinyl-4-methyl-2-piperidone, N-vinyl-5-methyl-2-piperidone, N-vinyl-6-methyl-2-piperidone, N-vinyl-6-ethyl- 2-Piperidinone, N-vinyl-3,5-dimethyl-2-piperidinone, N-vinyl-4,4-dimethyl-2-piperidinone, N-vinylcaprolactone, N-vinyl-3-methyl-2-caprolactone, N-vinyl-4-methyl-2-caprolactone, N-vinyl-7-methyl-2-caprolactone, N-vinyl-7-ethyl-2-caprolactone, N-vinyl-3,5-dimethyl-2-caprolactone - Dimethyl-2-caprolactam, N-vinyl-4,6-dimethyl-2-caprolactam, N-vinyl-3,5,7-trimethyl-2-caprolactam, N-vinyl-N-methylacetamide, N-vinylmethylamine, N-vinylacetamide, N-vinylisopropylamide, N-vinyl-N-ethylacetamide, N-vinyl-N-ethylmethylamine, and mixtures thereof; (6) A methylene-containing pyrrolidone monomer selected from the group consisting of: 1-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 1-n-propyl-3-methylene-2-pyrrolidone, 1-n-propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3-methylene-2-pyrrolidone, 1-isopropyl-5-methylene-2-pyrrolidone, 1-n-butyl-3-methylene-2-pyrrolidone, 1-tert-butyl-3-methylene-2-pyrrolidone, and combinations thereof; (7) having C1-C 4-alkoxyethoxy and acrylic monomers selected from the group consisting of: ethylene glycol methyl ether (meth)acrylate, di(ethylene glycol) methyl ether (meth)acrylate, tri(ethylene glycol) methyl ether (meth)acrylate, tetra(ethylene glycol) methyl ether (meth)acrylate, C1-C64 monomers having a number average molecular weight of up to 1500.4-Alkoxy poly(ethylene glycol) (meth)acrylate, methoxy-poly(ethylene glycol)ethyl (meth)acrylamide having a number average molecular weight of up to 1500, and combinations thereof; (8) vinyl ether monomers selected from the group consisting of: ethylene glycol monovinyl ether, di(ethylene glycol) monovinyl ether, tri(ethylene glycol) monovinyl ether, tetra(ethylene glycol) monovinyl ether, poly(ethylene glycol) monovinyl ether, ethylene glycol methyl vinyl ether, di(ethylene glycol) methyl vinyl ether, tri(ethylene glycol) methyl vinyl ether, tetra(ethylene glycol) methyl vinyl ether, poly(ethylene glycol) methyl vinyl ether, and combinations thereof; (9) Allyl ether monomers selected from the group consisting of: ethylene glycol monoallyl ether, di(ethylene glycol) monoallyl ether, tri(ethylene glycol) monoallyl ether, tetra(ethylene glycol) monoallyl ether, poly(ethylene glycol) monoallyl ether, ethylene glycol methyl allyl ether, di(ethylene glycol) methyl allyl ether, tri(ethylene glycol) methyl allyl ether, tetra(ethylene glycol) methyl allyl ether, poly(ethylene glycol) methyl allyl ether, and combinations thereof; (10)Ethylene monomers containing phosphatidylcholine selected from the following groups: (meth)propenylated ethyl phosphatidylcholine, (meth)propenylated propyl phosphatidylcholine, 4-((meth)propenylated)butyl-2'-(trimethylammonium)ethyl phosphate, 2-[(meth)propenylated amino]ethyl-2'-(trimethylammonium)-ethyl phosphate, 3-[(meth)propenylated amino]propyl-2'-(trimethylammonium)ethyl-phosphate, 4-[(meth)propenylated amino]butyl-2'- 5-(trimethylammonium)ethyl phosphate, 5-((meth)acryloxy)pentyl-2'-(trimethylammonium)ethyl phosphate, 6-((meth)acryloxy)hexyl-2'-(trimethylammonium)ethyl phosphate, 2-((meth)acryloxy)ethyl-2'-(triethylammonium)ethyl phosphate, 2-((meth)acryloxy)ethyl-2'-(tripropyl-ammonium)ethyl phosphate, 2-((meth)acryloxy)ethyl-2'-(tributylammonium)ethyl phosphate 2-((meth)propenyloxy)propyl-2'-(trimethylammonium)-ethyl phosphate, 2-((meth)propenyloxy)butyl-2'-(trimethylammonium)ethyl phosphate, 2-((meth)propenyloxy)pentyl-2'-(trimethylammonium)ethyl phosphate, 2-((meth)propenyloxy)hexyl-2'-(trimethylammonium)ethyl phosphate, 2-(vinyloxy)ethyl-2'-(trimethylammonium)ethyl phosphate, 2-(allyloxy)ethyl-2'-( (11) Trimethylammonium) ethyl phosphate, 2-(vinyloxycarbonyl)ethyl-2'-(trimethylammonium) ethyl phosphate, 2-(allyloxycarbonyl)ethyl-2'-(trimethylammonium) ethyl phosphate, 2-(vinyl-carbonylamino)ethyl-2'-(trimethylammonium) ethyl phosphate, 2-(allyloxycarbonylamino)ethyl-2'-(trimethylammonium) ethyl phosphate, 2-(butenyloxy)ethyl-2'-(trimethylammonium) ethyl phosphate, and combinations thereof; (12) allyl alcohol; (13) N-2-hydroxyethyl vinylaminocarbamate; (14) N-carboxyvinyl-β-alanine (VINAL); (15) N-carboxyvinyl-α-alanine; or combinations thereof.

15. The method as described in claim 14, wherein, The lens forming composition comprises: at least one blend of vinyl monomers; said at least one blend of vinyl monomers includes C1-C10 alkyl esters of (meth)acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, isobornyl acrylate of (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tributylstyrene (TBS), trifluoroethyl acrylate, hexafluoro-isopropyl acrylate, hexafluorobutyl acrylate, or combinations thereof; and at least one polymerizable component selected from the group consisting of: UV-absorbing vinyl monomers, UV / HEVL-absorbing vinyl monomers, photochromic vinyl monomers, polymerizable dyes, and combinations thereof. Or a combination thereof.