Contact lens insert edge design for optimal performance.

Abstract

A bilayer contact lens having an insert embedded in a bulk hydrogel material, the insert including at least one peripheral edge, the peripheral edge of the insert configured to provide improved lens performance through selective application of at least one design parameter selected from width, angle, shape configuration, and combinations thereof, at the peripheral edge of the insert.

Description

[Technical Field]

[0001] The present invention relates generally to the field of vision correction, and more particularly to a two-layer contact lens comprising an insert portion surrounded by a carrier portion made of a bulk material, the insert portion comprising one layer of bulk material and a circular or annular insert made of a layer of cross-linked polymeric material. [Background technology]

[0002] Presbyopia results from a gradual loss of accommodation in the human eye's visual system. This is due to an increase in the elastic modulus and bulge of the eye's lens, located immediately behind the iris and pupil. Tiny muscles within the eye, called the ciliary muscles, stretch or relax the lens, thereby adjusting its curvature. Adjusting the lens's curvature results in an adjustment of the eye's focusing power to focus on nearby objects. As people age, the eye's lens becomes less flexible and elastic, and to a lesser extent, the ciliary muscles become less powerful. These changes result in a decrease in the magnitude of accommodation (i.e., loss of accommodation), which causes objects near the eye to appear blurry. Presbyopia symptoms result in an inability to focus on objects close to the eye. As the lens's elastic modulus increases, images of intermediate and near distances cannot be formed on the retina. People with the condition typically have difficulty reading small print, such as that on computer display monitors, restaurant menus, and newspaper advertisements, and may need to hold reading material at arm's length.

[0003] A variety of non-surgical correction systems are currently used to treat presbyopia, including bifocals, progressive (non-linear) glasses, reading glasses, bifocal contact lenses, and monovision contact lenses. Surgical correction systems include, for example, multifocal and accommodating intraocular lenses (IOLs) that are inserted into the eye, and vision systems that are altered through keratectomy techniques.

[0004] A bilayer contact lens for correcting presbyopia may include a lens insert portion embedded in or applied onto a carrier portion, forming an insert-carrier interface between the lens insert portion and the carrier portion. The insert portion is typically formed from a material having a refractive index substantially different from that of the carrier portion. Some bilayer contact lenses have been found to impart optical (Fresnel) distortion within the wearer's field of vision due to the different refractive indices of the insert and carrier, and / or to be prone to delamination or separation of the insert from the carrier, warping or deformation of the lens material, and / or surface irregularities at the contact lens surface interface, all of which adversely affect lens performance. Delamination and material warping may sometimes be controlled to some extent by means such as adhesion promotion and selective material combinations, and clinical performance (e.g., comfort) may sometimes be controlled to some extent by the design of the carrier and insert, independent of the edges. However, increasing adhesion promotion or limiting material selection may place further undesirable limitations on overall lens design and performance, may result in increased performance issues such as increased deformation and / or delamination, and / or may impact clinical performance, such as adversely affecting comfort. Summary of the Invention [Problem to be solved by the invention]

[0005] It can thus be seen that there is a need for improved insert edge and insert-carrier interface designs for dual layer contact lenses. The present invention is primarily directed to providing improved insert edge and insert-carrier interface designs for dual layer contact lenses that meet these and other needs. [Means for solving the problem]

[0006] In exemplary embodiments, the present invention provides improved insert edge and insert-carrier interface designs for dual-layer contact lenses. It has been found that various factors, including the width, angle, geometric configuration, and / or location of the insert edge and the interface between the insert and carrier portions, as well as combinations of these factors, can significantly affect lens performance. Exemplary embodiments of the present invention are directed to improving and optimizing the insert edge design and insert-carrier interface of dual-layer contact lenses. Exemplary embodiments of the insert edge and insert-carrier interface designs according to the present invention may provide improved or optimized optical performance of the lens, better control or eliminate optical (Fresnel) distortion within the wearer's field of view, reduce or eliminate delamination or separation of the insert from the carrier, reduce or eliminate warping or deformation of the lens material, minimize or eliminate surface irregularities at the insert-carrier interface on the contact lens surface, and / or reduce or eliminate wearer discomfort.

[0007] In one aspect, the present invention relates to a bilayer contact lens comprising an anterior surface, an opposing posterior surface, a bulk hydrogel material, and an insert embedded in the bulk hydrogel material. The insert is made of a polymeric material different from the bulk hydrogel material and has a convex surface, an opposing concave surface, and a peripheral edge. The insert is located in an insert portion of the bilayer contact lens, which is surrounded by a carrier portion made of bulk hydrogel material. The insert portion includes the insert and a layer of bulk hydrogel material that directly contacts the insert via one of the convex and concave surfaces. The peripheral edge of the insert is configured to provide improved lens performance. In various preferred embodiments, the peripheral edge of the insert is configured to optimize lens performance through selective application of at least one design parameter selected from width, angle, shape configuration, and combinations thereof at the peripheral edge of the insert.

[0008] In another aspect, the present invention relates to a method for optimizing the performance of a bilayer contact lens. The contact lens includes an anterior surface, an opposing posterior surface, a bulk hydrogel material, and an insert embedded in the bulk hydrogel material. The insert is made of a polymeric material different from the bulk hydrogel material and has a convex surface, an opposing concave surface, and a periphery. The insert is located in an insert portion of the bilayer contact lens, which is surrounded by a carrier portion made of bulk hydrogel material. The insert portion includes the insert and a layer of bulk hydrogel material that directly contacts the insert via one of the convex and concave surfaces. The method includes selectively applying at least one design parameter selected from width, angle, configuration, and combinations thereof, at the periphery of the insert.

[0009] These and other aspects, features, and advantages of the present invention will be understood with reference to the drawings and detailed description herein and realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that the foregoing summary and the following brief description of the drawings and detailed description of exemplary embodiments are intended to describe exemplary embodiments of the invention and are not intended to limit the invention as claimed. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a plan view of a dual layer contact lens having a lens insert portion and a carrier portion according to an exemplary embodiment of the present invention. [Figure 2A] 1 is a cross-sectional view of a dual layer contact lens having a lens insert portion and a carrier portion according to an exemplary embodiment of the present invention. [Figure 2B] 2B is a detailed cross-sectional view of the insert-carrier interface of the contact lens of FIG. 2A. [Figure 3] 10 is a detailed cross-sectional view of another insert-carrier interface of a contact lens according to another exemplary embodiment. [Figure 4]10 is a detailed cross-sectional view of another insert-carrier interface of a contact lens according to another exemplary embodiment. [Figure 5A] 1 is a cross-sectional view of a dual-layer contact lens having a lens insert portion and a carrier portion according to another exemplary embodiment of the present invention. [Figure 5B] 5B is a detailed cross-sectional view of the insert-carrier interface of the contact lens of FIG. 5A. [Figure 6] 10 is a detailed cross-sectional view of another insert-carrier interface of a contact lens according to another exemplary embodiment. [Figure 7] 10 is a detailed cross-sectional view of another insert-carrier interface of a contact lens according to another exemplary embodiment. [Figure 8A] 1 is a plan view of a dual-layer contact lens having an annular lens insert portion and a carrier portion according to another exemplary embodiment of the present invention. [Figure 8B] FIG. 6B is a cross-sectional view of the contact lens of FIG. 6A. [Figure 9] 1 is a cross-sectional view of a contact lens according to another exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention may be understood more readily by reference to the following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings, which form a part of this disclosure. It is to be understood that the present invention is not limited to the specific devices, methods, conditions, or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only, and is not intended to limit the claimed invention. All patents and other publications identified herein are incorporated by reference as if fully set forth herein.

[0012] Also, as used in this specification, including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. Also, any use of the terms "about," "approximately," "substantially," and / or "generally" is intended to refer to the exact value or characteristic stated and to an approximation that will be understood by one of ordinary skill in the art to be sufficiently close to the exact value or characteristic based on the context of the intended use and application. Additionally, any method described herein is not intended to be limited to the order of the steps described, and other orders may be performed unless expressly stated otherwise herein.

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

[0014] "Hydrogel" or "hydrogel material" refers to a crosslinked polymeric material having a three-dimensional polymer network (i.e., a polymeric matrix) that is insoluble in water but can retain at least 10% by weight of water within its polymeric matrix when fully hydrated (or equilibrated).

[0015] "Silicone hydrogel" or "SiHy" refers to a silicone-containing hydrogel obtained by copolymerization of a polymerizable composition comprising at least one silicone-containing monomer or at least one silicone-containing macromer or at least one crosslinkable silicone-containing prepolymer.

[0016] Siloxane, often also called silicone, refers to a molecule that has at least one -Si-O-Si- moiety, where each Si atom has two organic groups as substituents.

[0017] As used in this application, the terms "non-silicone hydrogel" or "non-silicone hydrogel material" are interchangeable and refer to hydrogels that are theoretically free of silicon.

[0018] "Insert" refers to any three-dimensional article having dimensions of at least 5 microns but small enough to be embedded in the bulk material of an implantable hydrogel contact lens, and made of a material different from the bulk hydrogel material (preferably a non-hydrogel material).

[0019] According to the present invention, a non-hydrogel material can be any material that can absorb less than 5% by weight of water when fully hydrated (preferably about 4% by weight or less, more preferably about 3% by weight or less, and even more preferably about 2% by weight or less).

[0020] In accordance with the present invention, the insert of the present invention has a thickness that is less than any thickness of an implantable hydrogel contact lens in the area where the insert is embedded. The insert can be any object having any geometric shape and can have any desired function.

[0021] As used in this application, the terms "front surface," "front surface," "front curve surface," or "FC surface" in reference to a contact lens or insert are interchangeable and refer to the surface of the contact lens or insert that faces away from the eye during wear. The front surface (FC surface) is typically convex.

[0022] As used in this application, the terms "posterior surface," "back surface," "back curve surface," or "BC surface" in reference to a contact lens or insert are interchangeable and refer to the surface of the contact lens or insert that faces toward the eye during wear. The posterior surface (BC surface) is typically concave.

[0023] In exemplary embodiments, the present invention provides improved control of lens performance, e.g., in terms of lens deformation, delamination, and clinical performance and wearer comfort, in the design, manufacture, and use of bilayer contact lenses compared to known lenses, methods, and systems. The peripheral design of the insert is selected and implemented depending on the final bilayer lens design (e.g., thickness, diameter, etc.) and the combination of insert and carrier (i.e., bulk hydrogel) materials. In exemplary embodiments, the peripheral design optimizes or controls lens performance to reduce, minimize, or prevent deformation and / or delamination, while improving the clinical performance of the lens. The design and manufacturing process for the bilayer lens platform is flexible enough to realize a range of designs, providing great flexibility for controlling these parameters. In some specific embodiments of the present invention, the final parameters of the insert peripheral edge depend on factors including the overall lens design and material selection.

[0024] Referring now to the drawings, in which like reference numbers represent corresponding parts throughout the several views, FIG. 1 illustrates a contact lens 110 in plan view (i.e., a view from the front or back side of the lens) according to an exemplary embodiment of the present invention. Lens 110 is a two-layer contact lens having an insert portion 120 and an annular portion 130 made of bulk hydrogel material. In the exemplary embodiment, insert portion 120 and annular portion 130 are generally circular, and the insert portion is generally concentric with the annular portion, with the annular portion surrounding the insert portion in an annular or ring-like configuration. Insert portion 120 includes an insert 121 and a layer of bulk hydrogel material contiguous with the embedding surface of the insert.

[0025] The insert 121 includes a concave surface, an opposing convex surface that directly contacts the layer of bulk hydrogel material, and a peripheral edge 124. A generally circular radial insert-carrier interface 140 is defined between the peripheral edge 124 of the insert 121 and an annular portion 130 of the lens 110 that extends around the periphery or outer periphery or circumference of the insert 121. In some embodiments, for example, as described below with reference to FIGS. 2-4, the insert 121 can be embedded or applied to the base curve or back side of the lens 110. In other exemplary embodiments, for example, as described below with reference to FIGS. 5-7, the insert 121 can be embedded or applied to the front curve or anterior side of the lens 110. Depending on the thickness of the insert 121 and the geometry of the outer periphery of the insert 121, the insert-carrier interface 140 can extend across a widthwise or radial distance between the outer diameter or outer periphery (shown in solid lines) and the inner diameter or inner periphery (shown in dashed lines) at different depths within the lens body. In certain exemplary embodiments, the outer diameter of the entire lens 110 (i.e., measured at the outer periphery of the annular portion 130) can be about 12.5 mm to about 15.5 mm, e.g., about 14 mm, and the outer diameter of the lens insert 121 (i.e., measured at the insert-carrier interface 140) can be about 7 mm to 13 mm, e.g., about 10 mm. In exemplary embodiments, the insert 121 is formed of a first material having a first refractive index, and the annular portion and the layer of bulk hydrogel material are formed of a second material different from the first material, the second material having a second refractive index different from the first refractive index. In exemplary embodiments, the difference between the first and second refractive indices is at least about 0.05. In some exemplary embodiments, the lens insert portion 120 can include a diffractive lens element (i.e., an insert) formed of a relatively hard material and having a relatively high refractive index, and the lens carrier portion can include an insert made of a relatively soft material and having a relatively low refractive index. In alternative embodiments, the material selection can be reversed. In further exemplary embodiments, one or more additional layers, coatings, optical elements of the same or different materials may be provided on or within lens 110.

[0026] Any suitable insert material and any suitable carrier material (i.e., hydrogel material) can be used in the present invention. Examples of preferred insert and carrier materials include, but are not limited to, those disclosed in U.S. Patent Application Publication Nos. 2022 / 0324187, 2022 / 0326412, 2022 / 0306810, and 2023 / 0004023, all of which are incorporated by reference in their entireties.

[0027] In various preferred embodiments, the insert is made of a cross-linked polymeric material having a first refractive index, and the bulk hydrogel material (i.e., carrier material) is a silicone hydrogel material having a second refractive index, the first refractive index being at least 0.05 (preferably at least 0.07, more preferably at least 0.09, and even more preferably at least 0.10) higher than the second refractive index.

[0028] In preferred embodiments thereof, the crosslinked polymeric material of the insert has a refractive index of at least about 1.47, preferably at least about 1.49, more preferably at least about 1.51, and even more preferably at least about 1.53. Optionally, but preferably, the crosslinked polymeric material of the insert has 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. Such preferred insert materials are described in U.S. Patent Application Publication No. 2023 / 0004023, which is incorporated by reference in its entirety.

[0029] According to the present invention, the silicone hydrogel material (i.e., carrier material) has an equilibrium water content (i.e., in a fully hydrated state or when fully hydrated) of about 20% to about 70% by weight (preferably about 20% to about 65% by weight, more preferably about 25% to about 65% by weight, and even more preferably about 30% to about 60% by weight), an oxygen permeability of at least about 40 barrers (preferably at least about 60 barrers, more preferably at least about 80 barrers, and more preferably at least about 100 barrers), and an elastic modulus (i.e., Young's modulus) of about 1.5 MPa or less (preferably about 0.2 MPa to about 1.2 MPa, more preferably about 0.3 MPa to about 1.1 MPa, and even more preferably about 0.4 MPa to about 1.0 MPa). Such preferred carrier materials (i.e., silicone hydrogel materials) are described in U.S. Patent Application Publication No. 2023 / 0004023, which is incorporated by reference in its entirety.

[0030] 2A and 2B show a further exemplary embodiment of a contact lens 210 in side cross-sectional view, with an insert 221 embedded in the concave base curve or back side 212 of the lens in an insert portion 220 (i.e., the side of the lens that faces the wearer's eye in use, and a layer 226 of bulk hydrogel material in direct contact with the convex side of the insert 221), surrounded by an annular portion 230 of the lens carrier, defining an insert-carrier interface 240 in the region of the lens between the outer periphery of the insert and the carrier. The lens insert-carrier interface 240 is shown in more detail in FIG. 2B. As shown, the insert 221 extends beyond the overall thickness T of the lens body. c at least partially embedded in a thickness T i (The thickness is measured perpendicular to the tangent to the curvature of the lens.) In an exemplary embodiment, the thickness T i is the total lens thickness T cThe thickness is about 10% to about 90%, e.g., about 50%. In one example embodiment, an insert thickness of 25 μm and a lens body thickness of 115 μm corresponds to a total thickness of 140 μm. In another example embodiment, an insert thickness of 75 μm and a lens body thickness of 75 μm corresponds to a total thickness of 150 μm.

[0031] In some exemplary embodiments, as seen in more detail in FIG. 2B , the periphery of the insert 221 at the insert-carrier interface 240 includes a segmented edge geometry for improved lens performance. In the depicted embodiment, the insert-carrier interface 240 includes a tapered inner first segment 240A that is generally flat or linear in cross-sectional profile and generally frusto-conical in three-dimensional configuration, and an arcuate or curved outer or peripheral second segment 240B. In exemplary embodiments, the tapered first segment 240A spans a radial distance of about 0.1 to about 100 μm, e.g., about 25 μm, and the arcuate second segment 240B spans a radial distance of about 25 to about 500 μm, e.g., about 225 μm. In a further exemplary embodiment, the tapered first segment 240A can extend at an angle of about 90° to about 170°, e.g., about 120°, relative to a cylindrical axis parallel to the lens central axis A. In a further exemplary embodiment, the radius of curvature of the arcuate second segment 240B can be about 25 to 500 μm, e.g., a radius of about 225 μm. In a further exemplary embodiment, the insert-carrier interface 240 spans a radial distance or transition width W1 of about 0.25 to 0.5 mm, measured in a transverse direction perpendicular or orthogonal to the central axis A of the lens 210.

[0032] 3, the outer peripheral edge of the insert 320 defines a generally straight or linear frustoconical outer or peripheral surface oriented or tapered at an oblique angle (acute or obtuse) α with respect to a cylindrical axis A′ extending parallel to and concentric with the axial central axis A of the lens 310, and includes an angled, chamfered, or beveled edge 322 positioned a radial distance from the cylindrical axis A′ and tapering more widely outwardly toward the base curve or inner surface of the lens. The beveled edge 322 defines a width W2 between the inner and outer peripheral edges of the insert 320 in a transverse direction generally perpendicular to the axial direction of the central axis A. Selective control of the angle α and / or width W2 of the insert-carrier interface 340 between the insert 320 and the bulk hydrogel carrier lens material of the lens annular portion 330 allows for optimization and improved control of lens performance, e.g., to reduce, minimize, or prevent deformation and / or delamination, and / or to improve the clinical performance of the lens by, e.g., reducing, eliminating, or controlling optical (Fresnel) distortion and / or improving wearer comfort by making the insert-lens body interface less noticeable. In some specific exemplary embodiments, the angle α of the insert-carrier interface 340 between the beveled edge 322 and the cylindrical axis A′ is between about 1.0° and about 20.0°, e.g., about 10.00°. In a further specific example, the width W1 between the inner and outer peripheral edges of the insert 221 is between about 25 and 500 μm.

[0033] FIG. 4 illustrates in a detailed cross-sectional side view another exemplary embodiment of an insert-carrier interface of a dual-layer contact lens 410. Similar to the embodiments described above, the lens insert portion 420 is recessed into the concave base curve or backside 412 of the lens carrier portion 430. Rather than a rectangular transition, the outer peripheral edge of the insert 420 includes a rounded, radiused, or smoothly tapered transition configuration at the insert-carrier interface 440. The transition region of the insert-carrier interface 440 defines a width W3 between the inner and outer surfaces of the insert 420 in a transverse direction generally perpendicular to the axial direction of the central axis A of the lens 410. In some specific exemplary embodiments, the width W2 is between about 0.25 mm and about 0.5 mm, e.g., about 0.35 mm. Alternatively, the width W2 of the rounded transition region of the insert-carrier interface 440 may be greater than the thickness T of the insert 321. i For example, the width W2 may be determined proportionally to the thickness T i In another example, the width W2 is greater than or equal to the thickness T i or in a particular example, the width W2 is 0.75 to 1.5 times the thickness T i In exemplary embodiments, the radius of curvature of the insert lens edge is large enough so that it does not curl under itself and create an overhang. This generally depends on the thickness of the insert; thicker inserts typically utilize a larger radius of curvature at the insert edge.

[0034] FIG. 5A illustrates a further exemplary embodiment of a contact lens 510 in cross-sectional side view. In this embodiment, an insert 520 is embedded in the convex front curve or anterior side 512 of the lens (i.e., the side of the lens that faces away from the wearer's eye during use), and a layer of bulk hydrogel material 526 is directly in contact with and contiguous with the concave surface of the insert 421 in an insert portion 522 surrounded by an annular portion 530, but is otherwise substantially similar to the above-described embodiment. An insert-carrier interface 540 is defined in the region of the lens 510 between the outer periphery of the insert 520 and the bulk hydrogel carrier material of the lens annular portion 530. The lens insert-carrier interface 540 is shown in more detail in FIG. 5B. As shown, the insert 520 extends beyond the entire thickness T of the lens body. c at least partially embedded in a thickness T i In an exemplary embodiment, the thickness T i is the thickness T c25% to about 75%, e.g., about 50%. In the depicted exemplary embodiment, the outer peripheral edge of the insert 520 at the insert-carrier interface 540 includes a segmented edge geometry for improved lens performance. The segmented edge geometry includes a tapered inner first segment 540A that is generally flat or linear in cross-sectional profile and generally frusto-conical in three-dimensional configuration, and an arcuate or curved outer or peripheral second segment 540B. In the exemplary embodiment, the tapered first segment 540A spans a radial distance of about 0 to 100 μm, e.g., about 25 μm, and the arcuate second segment 540B spans a radial distance of about 25 to 500 μm, e.g., about 225 μm. In a further exemplary embodiment, the tapered first segment 540A can extend at an angle of about 90° to 170°, e.g., about 120°, relative to a cylindrical axis parallel to the lens central axis A. In a further exemplary embodiment, the radius of curvature of the arcuate second segment 540B can be about 25 to 500 μm, e.g., a radius of about 225 μm. In a further exemplary embodiment, the insert-carrier interface 540 spans a radial distance or transition width W4 of about 0.25 to 0.5 mm, measured in a transverse direction perpendicular or orthogonal to the central axis A of the lens 510.

[0035] 6 shows another exemplary embodiment of a lens 610 having an insert 620 on a convex front curve 612 of the lens surrounded by an annular carrier lens portion 630. The insert 620 defines a generally straight or linear frustoconical outer or peripheral surface oriented or tapered at an oblique angle (acute or obtuse) α with respect to a cylindrical axis A′ extending parallel to and concentric with an axial central axis A of the lens 610, and includes an angled, chamfered, or beveled edge 624 positioned a radial distance from the cylindrical axis A′ and tapering more widely outward toward the front curve or outer surface 612 of the lens. The beveled edge 624 defines a width W5 between inner and outer peripheral edges of the insert 620 in a transverse direction generally perpendicular to the axial direction of the central axis A. Selective control of the angle α and / or width W5 of the insert-carrier interface 640 allows for optimization and improved control of lens performance, e.g., to reduce, minimize, or prevent deformation and / or delamination, and / or to improve the clinical performance of the lens, e.g., by reducing, eliminating, or controlling optical (Fresnel) distortion and / or improving wearer comfort. In some specific exemplary embodiments, the angle α of the insert-carrier interface 440 between the beveled edge 424 and the cylindrical axis A′ is between about 0° and about 175°, e.g., about 60°. In further specific exemplary embodiments, the width W3 between the inner and outer peripheral edges of the insert 421 is between about 0.25 mm and about 1.0 mm, e.g., about 0.35 mm.

[0036] FIG. 7 illustrates in a detailed cross-sectional side view another exemplary embodiment of an insert-carrier interface of a dual-layer contact lens 710. Similar to the embodiments of FIGS. 5 and 6 described above, an insert 720 is embedded in the convex front curve or anterior side 712 of the lens in an insert portion 722, which is surrounded by an annular lens portion 730. Rather than a rectangular transition, the outer peripheral edge of the insert 720 includes a rounded, radiused, or smoothly tapered transition configuration at the insert-carrier interface 740. The transition region of the insert-carrier interface 740 defines a width W6 between the inner and outer surfaces of the insert 720 in a transverse direction generally perpendicular to the axial direction of the central axis A. In some specific exemplary embodiments, the width W6 is between about 0.1 mm and about 1 mm, e.g., about 0.35 mm. Alternatively, the width W4 of the rounded transition region of the insert-carrier interface 740 may be greater than the thickness T of the insert 720. i For example, the width W4 may be determined proportionally to the thickness T i In another example, the width W4 is equal to or greater than the thickness T i or in a particular example, the width W4 is 0.75 to 1.5 times the thickness T i It is about 1.0 to 1.25 times the

[0037] 8A and 8B show a plan view of a further exemplary embodiment of a contact lens 800. The contact lens 800 includes a circular central lens portion 810 immediately surrounded by an insert portion 820, which is directly surrounded by a lens carrier annular portion 830. In this embodiment, both the central lens portion 810 and the lens carrier annular portion 830 are made of bulk hydrogel material, and the insert portion 820 has an annular ring-shaped region and includes an insert 822 and a layer of bulk hydrogel material 826. The insert 822 has a concave surface that smoothly continues the lens base curve, an opposing convex surface that continues with the layer of bulk hydrogel material 826, an inner peripheral edge 842, and an outer peripheral edge 844. The insert portion 820 is disposed substantially concentrically with the circular central lens portion 810. The lens 800 is otherwise substantially similar to the embodiments described above. In some exemplary embodiments, lens 810 may have a clear central opening, such as for use in treating myopia. In exemplary embodiments, the entire lens 810 may have an outer diameter of approximately 14 mm, with outer peripheral edge 844 having a diameter of approximately 7-13 mm and inner peripheral edge 842 having a diameter of approximately 2-5 mm. As shown in FIG. 8B, insert 821 may be embedded in or applied to the base curve or back surface of the lens, or alternatively, as shown in FIG. 9, an annular insert 922 may be embedded in or applied to the front curve or front surface of lens 900 in an otherwise similar manner. Also, in different exemplary embodiments, the periphery of the insert may be segmented as in FIGS. 2 and 5, or generally rectangular as in FIGS. 3 and 6, or rounded or radiused as in FIGS. 4 and 7, or otherwise configured.

[0038] The present invention includes systems and methods for designing, manufacturing, and / or using contact lenses, as well as the contact lenses themselves. The design of the insert edge and the location, configuration, and geometry of the insert-carrier interface affect lens performance. Different design features and parameters included in exemplary systems and methods of the present invention include selective control of the width, angle, and geometry (e.g., straight edge vs. curved edge) of the insert edge and insert-carrier interface of a two-layer contact lens. Lens deformation and delamination can be a major issue depending on the type / combination of materials used. Different materials and overall lens designs (such as insert thickness) may require different shapes. The exemplary edge designs are intended to solve challenges related to lens shape and manufacturing.

[0039] In an exemplary embodiment, a lens according to the present disclosure may be manufactured by a molding process including the following steps. For lenses with an insert lens on the base curve: - pouring an insert compound into a first female mold; Engaging the male mold to form the insert; Hardening the insert; Removing the male mold with the insert attached to the male mold; pouring the bulk hydrogel formulation into a second female mold to form a bulk hydrogel portion; engaging the male mold with the insert attached to the second female mold; The hardening step completes the lens. Or alternatively, for lenses with an insert lens on the base curve: Pouring the bulk hydrogel formulation into a female mold; engaging and curing the first male mold half to form the bulk hydrogel portion of the lens (having a recess in which the insert lens will be formed); - pouring the insert lens compound into the female mold half (into the recess left by the previous step); Engaging the second male mold half and curing to form the complete lens. Also, in the case of lenses with an insert lens on the front curve, - introducing the insert lens compound into the female mold half; engaging and curing the first male mold half to form an insert lens; Removing the first male mold half and dispensing a bulk hydrogel formulation into the female mold half to encapsulate the insert lens; Engaging the second male mold half and curing to form the complete lens. Additionally, in an exemplary embodiment, the lens mold angle may preferably be greater than zero to create a draft angle for removal from the mold. If a particular material proves difficult to remove from the mold, increasing the mold angle will make removal easier.

[0040] The disclosed exemplary embodiments illustrate some of the variables that can be controlled to produce desired results. Many parameters are adjustable and within the scope of the present invention, including width, angle, and tapered insert edges versus straight insert edges, as well as insert-carrier interface configuration. In some exemplary embodiments, the final design of a particular insert edge and / or insert-carrier interface will depend on the materials used and the desired performance of a particular lens. Accordingly, the lens designs, and systems and methods for designing, manufacturing, and using lenses, disclosed herein are within the scope of the present invention as exemplary embodiments and are not intended to be limiting. Additionally, as illustrated below, it should be understood that aspects of various embodiments of the present invention, such as the following exemplary embodiments, may be interchanged in whole or in part, or may be combined in any manner and / or used together.

[0041] 1. A bilayer contact lens comprising an anterior surface, an opposing posterior surface, a bulk hydrogel material, an insert embedded in the bulk hydrogel material, an insert portion, and a carrier portion, wherein the insert is made of a crosslinked polymeric material different from the bulk hydrogel material and has a convex surface, an opposing concave surface, and at least one peripheral edge, wherein the insert portion is directly surrounded by the carrier portion made of bulk hydrogel material, the insert portion including the insert and a layer of bulk hydrogel material in direct contact with the insert via one of the convex and concave surfaces, wherein the at least one peripheral edge of the insert is configured to provide improved lens performance.

[0042] 2. The bilayer contact lens of embodiment 1, wherein the bilayer contact lens has a diameter of about 12.5 mm to about 15.5 mm, and wherein the at least one peripheral edge of the insert is configured to provide improved lens performance through selective application of at least one design parameter selected from width, angle, shape configuration, and combinations thereof, at the peripheral edge of the insert.

[0043] 3. The dual layer contact lens of embodiment 1 or 2, wherein the at least one peripheral configuration of the insert is selected from a flat configuration or a rounded configuration.

[0044] 4. The two-layer contact lens of any one of embodiments 1-3, wherein the layer of bulk hydrogel material within the insert portion is in direct contact with the convex surface of the insert.

[0045] 5. The two-layer contact lens of any one of embodiments 1-3, wherein the layer of bulk hydrogel material within the insert portion directly contacts the concave surface of the insert.

[0046] 6. A two-layer contact lens according to any one of embodiments 1 to 5, wherein the at least one peripheral edge of the insert comprises a segmented edge geometry including a tapered inner first segment and an outer second segment, the tapered inner first segment having a flat or straight cross-sectional profile (a truncated cone in three-dimensional configuration) while the tapered outer second segment has an arcuate or curved cross-sectional profile.

[0047] 7. The bilayer contact lens of embodiment 6, wherein the tapered inner first segment spans a radial distance of from about 0.1 to about 100 μm, and the tapered outer second segment spans a radial distance of from about 25 to about 500 μm.

[0048] 8. The bilayer contact lens of embodiment 6 or 7, wherein the tapered inner first segment extends at an angle of about 90° to about 170° relative to a cylindrical axis parallel to the central axis of the bilayer contact lens.

[0049] 9. The two-layer contact lens of any one of embodiments 6 to 8, wherein the tapered outer second segment is arcuate and has a radius of curvature of from about 25 to about 500 μm.

[0050] 10. A bilayer contact lens according to any one of embodiments 6 to 9, wherein the at least one peripheral edge of the insert spans a radial distance of about 0.25 mm to about 0.5 mm measured in a transverse direction perpendicular or orthogonal to the central axis of the bilayer contact lens.

[0051] 11. A bilayer contact lens according to any one of embodiments 1 to 5, wherein the at least one peripheral edge is an angled, chamfered or beveled edge defining a straight or linear frustoconical peripheral side surface that is oriented or tapered at an oblique angle (acute or obtuse) relative to a cylindrical axis that is parallel to and concentric with the central axial axis of the bilayer contact lens, is positioned at a radial distance from the cylindrical axis and tapers more widely outward toward the base curve of the bilayer contact lens.

[0052] 12. The bilayer contact lens of embodiment 11, wherein the angled, chamfered, or beveled edge spans a radial distance of about 25 μm to about 500 μm, measured in a transverse direction perpendicular or orthogonal to the central axis of the bilayer contact lens.

[0053] 13. A bilayer contact lens according to any one of embodiments 1 to 5, wherein the at least one peripheral edge is a rounded, radiused, or smoothly tapered peripheral edge spanning a radial distance of about 0.25 mm to about 0.50 mm measured in a transverse direction perpendicular or orthogonal to the central axis of the bilayer contact lens.

[0054] 14. A two-layer contact lens according to any one of embodiments 1 to 13, wherein the insert has an annular ring shape, the at least one peripheral edge includes an inner peripheral edge and an outer peripheral edge, and the insert portion immediately surrounds the circular central lens portion.

[0055] 15. The two-layer contact lens of embodiment 14, wherein the outer periphery of the insert has a diameter of about 7 mm to about 13 mm, and the inner periphery of the insert has a diameter of about 2 mm to about 5 mm.

[0056] 16. The two-layer contact lens of any one of embodiments 1-13, wherein the insert has a circular shape and includes only one peripheral edge.

[0057] 17. The bilayer contact lens of any one of embodiments 1-16, wherein the improved lens performance provided relates to at least one of resistance to lens deformation, resistance to delamination of the insert from the bulk hydrogel material, control of optical distortion, and / or improved wearer comfort.

[0058] 18. The two-layer contact lens of any one of embodiments 1 to 17, wherein the insert has an outer diameter of 7 mm to 13 mm.

[0059] 19. The two-layer contact lens of any one of embodiments 1-18, wherein the crosslinked polymeric material of the insert has a first refractive index of at least 1.47 and an oxygen permeability of at least 40 barrers.

[0060] 20. The two-layer contact lens of embodiment 19, wherein the hydrogel bulk material has a second refractive index, the difference between the first and second refractive indices being at least about 0.05.

[0061] 21. The two-layer contact lens of any one of embodiments 1-20, wherein the insert comprises a diffractive lens element.

[0062] 22. A method for optimizing the performance of a bilayer contact lens comprising an anterior surface, an opposing posterior surface, a bulk hydrogel material, an insert embedded in the bulk hydrogel material, an insert portion, and a carrier portion, wherein the insert is made of a crosslinked polymeric material different from the bulk hydrogel material and has a convex surface, an opposing concave surface, and at least one periphery, the insert portion being directly surrounded by a carrier portion made of bulk hydrogel material, the insert portion comprising the insert and a layer of bulk hydrogel material directly contacting the insert via one of the convex and concave surfaces, the method comprising selectively applying at least one design parameter selected from width, angle, configuration, and combinations thereof, at the periphery of the insert.

[0063] 23. The method of embodiment 22, wherein the insert-carrier interface configuration of the at least one peripheral edge of the insert is selected from a flat configuration or a rounded configuration.

[0064] 24. The method of embodiment 22 or 23, wherein the layer of bulk hydrogel material within the insert portion is in direct contact with the convex surface of the insert.

[0065] 25. The method of any one of embodiments 22-24, wherein the layer of bulk hydrogel material within the insert portion is in direct contact with the concave surface of the insert.

[0066] 26. The method of any one of embodiments 22-25, wherein the insert has an annular ring shape and includes an inner periphery and an outer periphery.

[0067] 27. The method of any one of embodiments 22 to 26, wherein the optimized lens performance provided relates to at least one of resistance to lens deformation, resistance to delamination of the insert portion from the bulk hydrogel material, control of optical distortion, and / or improved wearer comfort.

[0068] Although the present invention has been described with reference to exemplary embodiments, those skilled in the art will appreciate that various modifications, additions, and deletions are within the scope of the invention, as defined by the claims that follow.

Claims

1. 1. A bilayer contact lens comprising: an anterior surface, an opposing posterior surface, a bulk hydrogel material, an insert embedded in the bulk hydrogel material, an insert portion, and a carrier portion, wherein the insert is made of a crosslinked polymeric material different from the bulk hydrogel material and has a convex surface, an opposing concave surface, and at least one peripheral edge, the insert portion being directly surrounded by a carrier portion made of bulk hydrogel material, the insert portion including the insert and a layer of the bulk hydrogel material directly contacting the insert via one of the convex and concave surfaces, the at least one peripheral edge of the insert being configured to provide improved lens performance, the bilayer contact lens having a diameter of about 12.5 mm to about 15.5 mm, and the at least one peripheral edge of the insert being configured to provide improved lens performance by selective application of at least one design parameter selected from width, angle, shape configuration, and combinations thereof, at the peripheral edge of the insert.

2. 10. The bi-layer contact lens of claim 1, wherein the configuration of the at least one peripheral edge of the insert is selected from a flat configuration or a rounded configuration.

3. 3. The two-layer contact lens of claim 1, wherein the at least one peripheral edge of the insert comprises a segmented edge geometry including a tapered inner first segment and an outer second segment, the tapered inner first segment having a flat or straight cross-sectional profile (frustoconical in three-dimensional configuration) while the tapered outer second segment has an arcuate or curved cross-sectional profile, the tapered inner first segment spanning a radial distance of about 0.1 to about 100 μm, and the tapered second segment spanning a radial distance of about 25 to about 500 μm.

4. 4. The two-layer contact lens of claim 3, wherein the tapered inner first segment extends at an angle of about 90° to about 170° relative to a cylindrical axis of the two-layer contact lens that is parallel to the lens central axis, and / or the tapered outer second segment is arcuate and has a radius of curvature of about 25 to about 500 μm.

5. 5. The bilayer contact lens of claim 3, wherein the at least one peripheral edge of the insert spans a radial distance of about 0.25 mm to about 0.5 mm measured in a transverse direction perpendicular or orthogonal to the central axis of the bilayer contact lens.

6. 3. The bilayer contact lens of claim 1, wherein the at least one peripheral edge is an angled, chamfered, or beveled edge defining a straight or linear frustoconical peripheral side surface that is oriented or tapered at an oblique angle (acute or obtuse) relative to a cylindrical axis that is parallel to and concentric with the axial central axis of the bilayer contact lens, is positioned at a radial distance from the cylindrical axis, and tapers more widely outward toward the base curve of the bilayer contact lens.

7. 7. The bilayer contact lens of claim 6, wherein the angled, chamfered, or beveled edge spans a radial distance of about 25 μm to about 500 μm measured in a transverse direction perpendicular or orthogonal to the central axis of the bilayer contact lens.

8. 3. The bilayer contact lens of claim 1, wherein the at least one peripheral edge is a rounded, radiused, or smoothly tapered peripheral edge spanning a radial distance of about 0.25 mm to about 0.50 mm measured in a transverse direction perpendicular or orthogonal to the central axis of the bilayer contact lens.

9. 9. The two-layer contact lens of claim 1, wherein the insert has an annular ring shape, the at least one peripheral edge includes an inner peripheral edge and an outer peripheral edge, and the insert portion immediately surrounds a circular central lens portion.

10. 10. The two-layer contact lens of claim 9, wherein the outer periphery of the insert has a diameter of about 7 mm to about 13 mm and the inner periphery of the insert has a diameter of about 2 mm to about 5 mm.

11. The two-layer contact lens of any one of claims 1 to 7, wherein the insert has a circular shape and includes only one peripheral edge.

12. 12. The two-layer contact lens of any one of claims 1 to 11, wherein the improved lens performance provided relates to at least one of resistance to lens deformation, resistance to delamination of the insert from the bulk hydrogel material, control of optical distortion, and / or improved wearer comfort.

13. 18. The two-layer contact lens of any one of claims 1 to 17, wherein the insert has an outer diameter of 7 mm to 13 mm and includes a diffractive lens element, the crosslinked polymeric material of the insert has a first refractive index of at least 1.47 and an oxygen permeability of at least 40 barrers, and the bulk hydrogel material has a second refractive index, the difference between the first and second refractive indices being at least about 0.

05.

14. 1. A method of optimizing performance of a bilayer contact lens comprising: an anterior surface, an opposing posterior surface, a bulk hydrogel material, an insert embedded in the bulk hydrogel material, an insert portion, and a carrier portion, wherein the insert is made of a crosslinked polymeric material different from the bulk hydrogel material and has a convex surface, an opposing concave surface, and at least one periphery, the insert portion being directly surrounded by a carrier portion made of the bulk hydrogel material, the insert portion including the insert and a layer of the bulk hydrogel material directly contacting the insert via one of the convex and concave surfaces, the method comprising selectively applying at least one design parameter selected from width, angle, configuration, and combinations thereof, at the periphery of the insert.

15. The method of claim 14, wherein the insert-carrier interface configuration of the at least one peripheral edge of the insert is selected from a flat configuration or a rounded configuration.

16. 16. The method of claim 14 or 15, wherein the insert has an annular ring shape and includes an inner peripheral edge and an outer peripheral edge, and / or the optimized lens performance provided relates to at least one of resistance to lens deformation, resistance to delamination of the insert portion from the bulk hydrogel material, control of optical distortion, and / or improved wearer comfort.

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