WO2013125470A1

WO2013125470A1 - Colored contact lens

Info

Publication number: WO2013125470A1
Application number: PCT/JP2013/053773
Authority: WO
Inventors: 知章横田
Original assignee: 株式会社メニコンネクト
Priority date: 2012-02-20
Filing date: 2013-02-18
Publication date: 2013-08-29
Also published as: JPWO2013125470A1; CN104246580B; KR20140097491A; CN104246580A; JP5369273B1; KR101612743B1

Abstract

[Problem] The purpose of the present invention is to propose a design for a contact lens which can impart natural appearance to eyes of a person who wears the contact lens and can change the original color or texture of the eyes objectively, and to provide a colored contact lens which can be produced at a reduced cost without adversely affecting physical properties inherent in the contact lens. [Solution] The colored contact lens according to the present invention has a transparent central visual area and a colored area surrounding the central visual area, said colored contact lens being characterized in that the colored area essentially has a sea-island structure composed of a continuous transparent part as a sea part and discontinuous colored opaque parts as island parts, wherein each of the colored opaque parts has a scaly shape and has a size of 70 to 600 μm as measured in the direction of the diameter of the lens and 40 to 300 μm as measured in the direction of the circumference of the lens.

Description

Colored contact lenses

The present invention relates to a colored contact lens having a colored pattern that gives a very natural appearance and can change the appearance of the wearer's pupil.

Colored contact lenses are for the purpose of enjoying fashion rather than for eyesight correction, and are mainly sold as soft contact lenses (some patients have abnormalities in the appearance of the iris or cornea of their eyes). Is used as an artificial eye for the purpose of beauty, which is also sold as a hard system).

Conventionally, if the objective is not to correct visual acuity among colored contact lenses, it has not been regulated by the Pharmaceutical Affairs Law. For this reason, in response to reports of health hazards that may have been caused by the product's completeness and inadequate sales / use guidance, the government has established a policy to regulate regulations within the framework of the Pharmaceutical Affairs Law. Since November 4, 2009, it was regulated as a “medical device”. A fashionable colored contact lens objectively changes the color or texture of the pupil. In order to change the color of Japanese pupils with particularly dark iris colors, it is necessary to use an opaque coloring agent to the extent that the iris color behind the lens cannot be seen. It is inferred that one of the causes of health damage is that the elution of the colorant was caused, or that the contact portion surface roughness at the colored portion and the oxygen permeability of the lens material were inhibited.

Contact lens coloring methods can be broadly divided into a method of uniformly coloring a lens using a dye and a method of printing a pattern partially on the surface or inside of a transparent (including a lightly colored lens) lens. The latter method is mainly employed for colored contact lenses that change the appearance of the wearer's pupil. For example, a colored contact lens is formed when the lens forming mold surface is coated with a colored monomer component on the surface forming the iris portion and then formed into a film, and then charged and polymerized with the lens monomer component and taken out of the mold. And a contact lens (Patent Document 2) in which a colored portion is embedded in a lens material. These are effective methods for producing colored contact lenses in that the elution of the colorant is suppressed and the smoothness of the lens surface is ensured.

In addition to these production methods, there are many design proposals that take into account visual effects. For example, at least two different designs are provided on the mold surface, and transferred to the surface of the lens that contacts the mold surface during molding and curing of the contact lens (Patent Document 3). Having a pattern in contact with the boundary area (Patent Document 4), two sub-patterns having different shadow ratios, and a subjective sub-pattern having a pattern composed of a series of radial intermittent lines (Patent Document) 5) Having an iris section composed of three parts, and by appropriately setting the range of each section, a region that overlaps at a plurality of locations is generated, and a very natural appearance (Patent Document 6), cornea An edge ring and a fibrous dot pattern that emphasizes the sharpness of the user's iris (Patent Document 7), and the colored region is circular, elliptical, Square, consists of a combination having a shape such as a linear, one having a color that changes gradually in a radial direction (Patent Document 8), and the like.

The natural iris structure does not have a single color even in dark colors like Japanese people, but includes many colors and patterns of different shapes. Naturally, it is natural that the user prefers to exhibit this natural appearance, and thus the various designs have been devised. Considering the design in terms of shape, it is basically a plane with a certain extent (such as covering the user's iris area), a continuous or intermittent line, a shape such as a circle, an ellipse, or a triangle. There are roughly three types of dots (dots) having Although the planar design is excellent in terms of the function of changing the appearance of the wearer's pupil, it is not necessarily preferable because it has a high risk of impeding the so-called oxygen permeability of the lens material, and the line or dot is not a dark pupil. It is difficult in terms of changing the apparent color.

Furthermore, in the case of lines or dots, there is a situation where it is difficult to predict the appearance due to the relationship (overlap) with the wearer's iris when the lens is attached to the eye, so that a desired design can be formed. A certain amount of trial and error is required, and an optimum design of the colored contact lens is required.

Japanese Patent Laid-Open No. 2-134612 JP-A-3-15020 JP-A-4-265710 JP-T-4-505972 JP 2000-66147 A Special Table 2002-507001 Special Table 2007-553792 JP-T-2004-533629

An object of the present invention is to propose a design that can objectively change the color and texture of a wearer's pupil while giving a natural appearance to the contact lens wearer's pupil. An object of the present invention is to provide a colored contact lens in which an increase in manufacturing cost is suppressed without adversely affecting various physical properties.

The present invention is a colored contact lens having a transparent central visual region and a colored region surrounding the central visual region, and the colored region basically includes a continuous transparent portion of the sea portion and a discontinuous coloring of the island portion. A sea-island structure including an opaque portion is formed, and the colored opaque portion has a scale-like shape, and has a size of 70 to 600 μm in the radial direction of the lens and 40 to 300 μm in the circumferential direction of the lens. . The colored opaque part makes the lens wearer's original pupil color and pattern appear to have changed when viewed from the observer. Furthermore, if each scale pattern is arranged wider than the original pupil of the lens wearer, there is an effect of making the iris part more conspicuous and making the pupil larger. For example, when a wearer with an outer diameter of 12 mm wears a colored contact lens with an outer diameter of a colored opaque portion of 13 mm, not only the pupil looks large but also a beautiful face with a sharp eye may appear.

In addition, for example, when producing a hydrous soft contact lens as a colored contact lens, the colored region of the present invention has a sea-island structure even when the lens size at the time of manufacture and at the time of use swells and becomes larger due to moisture. Since it has, there is no fear of deformation accompanying swelling. Although details will be described later, when a lens is manufactured by a so-called dry mold method, the lens size is greatly different between the time of manufacture and the time of use (including water). Usually, since the colored opaque portion contains a component that does not contain water, the moisture content of the transparent portion and the opaque portion does not always match, and the influence may be deformed. At this time, even if the average moisture content is matched, the moisture content may be partially different between the dark portion and the light portion. In the present invention, the design can cope with such a situation.

The scale-like shapes of the colored opaque portions are arranged toward the center of the lens and have a larger curvature in the center direction of the lens than in the outer periphery direction of the lens. As will be described later, the scale has a shape such that each corner of the isosceles triangle is rounded and each side is appropriately curved, and the base side is arranged in the outer peripheral direction of the lens. The bend formed at the isosceles portion (hereinafter also referred to as “front end side”) is directed toward the center of the lens and is larger than the bend formed at the base side (including a straight line shape; hereinafter also referred to as “rear end side”). By arranging the colored opaque portions in such an arrangement and shape, the iris pattern can be expressed in a more natural appearance.

The colored region may form a complete sea-island structure, but the colored opaque portion of the island portion may be partially connected. More specifically, a plurality of scaly island portions in an annular range having a width of 1 to 3.5 mm, more preferably in an annular range of 1.5 to 3.0 mm, from the periphery of the colored region toward the lens center. However, they may be connected to each other in the center direction of the lens and the outer peripheral direction of the lens. This is because it is possible to arrange more colored opaque portions, appropriately shield the sclera portion behind the lens, change the color and pattern of the pupil depending on the colored region, and make the pupil appear larger. In addition, the same effect can be acquired even if it does not connect an island part by enlarging the size of the colored opaque part of an island part.

It is preferable that the colored opaque portion is designed so that the size thereof becomes smaller or the number thereof becomes smaller as going toward the center of the lens. The size and number of the colored opaque portions can be changed independently of each other, and it is not necessary to color the lens so that the center side of the lens is smaller in size or the number is smaller than the outer peripheral side. It can be understood as a design trend and can be adjusted as appropriate. As a result, the iris can be expressed as a more natural appearance on the curved surface of the contact lens. A conventional dot pattern has been proposed to have a density gradient that reduces the number (see, for example, Patent Document 7), but no proposal has been found to reduce the size of the dot itself. In the present invention, considering that the natural iris is a thin membrane between the cornea and the crystalline lens, it is necessary to design perspective on the curved surface of the lens to make the iris more prominent. This is based on the idea that it is preferable to have a 3D effect.

Also, it is preferable that the central visual area has a diameter of 7 to 11 mm. This is to prevent the field of view from being obstructed by the opaque portion.

Furthermore, the outer diameter of the annular colored region is 11 to 14 mm, preferably 12 to 13.8 mm, more preferably 12.5 to 13.5 mm. Since the colored opaque portion only needs to cover the iris or a region slightly wider than the iris, it may have a transparent portion on the outside thereof. In particular, the soft contact lens has a size ranging from the cornea to the sclera, and does not have to create a coloring area that is wider than necessary, and if the pupil is too large, the appearance is not preferable. .

Since the colored contact lens of the present invention has a colored opaque portion formed in a scale shape, unlike a conventional flat, line, or dot design, even if it is a dark-colored pupil, the original A sense different from color can be effectively given. Moreover, since the way it looks is very close to a natural pupil, there is no sense of incongruity. Further, if the scale shape is arranged larger than the diameter of the pupil, the pupil can be made larger.

Further, even when the design of the present invention is applied to a method of manufacturing a hydrous soft contact lens by a dry mold, it is possible to suppress the deformation of the lens when it contains water.

FIG. 1 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 2 is a diagram showing an example of a method for producing a colored contact lens of the present invention. FIG. 3 is a diagram showing the design as dots as Comparative Example 1. FIG. 4 is a diagram showing the design as a curve as Comparative Example 2. FIG. 5 is a diagram showing the design as a comparative example 3 with a combination of lines having different thicknesses. FIG. 6 is a diagram showing the design as a ring as Comparative Example 4. FIG. 7 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 8 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 9 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 10 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 11 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 12 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 13 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 14 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 15 is a diagram showing an example of the design of the colored contact lens of the present invention. FIG. 16 is a diagram showing an example of the design of the colored contact lens of the present invention.

The colored contact lens of the present invention can make a person with a dark pupil feel a change in appearance due to a colored opaque portion having a specific shape, and is reflected in a natural pupil. It has the feature that it is difficult for a third party to see this. Hereinafter, description will be given with reference to the accompanying drawings.

The colored contact lens of the present invention includes a lens called a “color control” for enjoying fashion and a lens for correcting vision. The material of such a lens may be any of a water-containing soft contact lens containing water, a silicone hydrogel soft contact lens, a non-water-containing soft contact lens, and an oxygen-permeable hard contact lens.

The specific shape design of the present invention can be applied to any type of lens material described above, and is more suitable for hydrous soft contact lenses that are the mainstream in the colored contact lens market in recent years. Each lens material is a polymer of a known monomer. For example, as a hydrous soft contact lens, hydroxyalkyl (meth) acrylate, alkylene glycol mono (meth) acrylate, alkylaminoalkyl (meth) acrylate, dimethyl (meth) Polymers such as acrylamide, glycerol (meth) acrylate, glycidyl (meth) acrylate, vinyl pyrrolidone, (meth) acrylic acid, etc., and non-hydrous soft contact lens materials are polymers with a low glass transition point. Examples of such monomers include polymers such as n-butyl (meth) acrylate, decyl (meth) acrylate, and lauryl (meth) acrylate, which are used as materials for silicone hydrogel soft contact lenses and oxygen-permeable hard contact lenses. Include the polymers of monomers such as the above water-containing soft contact lenses monomers and silicone-containing macromer such as silicone-containing alkyl (meth) acrylate.

As described above, in the present invention, the constituent monomer of the contact lens is not particularly limited. However, when selecting the raw material which comprises a colored opaque part, you may mix | blend a monomer component other than a coloring component. As the monomer component to be blended, it is preferable to selectively use a monomer having a high affinity with the constituent monomer component of the contact lens to which the coloring is applied, for example, the same monomer as the constituent monomer. More specifically, if a high molecular weight polymer having hydroxyethyl methacrylate as a main component is selected as the material for the colored contact lens, it is desirable to add hydroxyethyl methacrylate as the material for forming the colored opaque portion. It is. Thereby, the coloring component with respect to the contact lens main body is more firmly bonded, and it is possible to effectively prevent elution of the coloring agent and the like and to prevent deformation of the lens after molding. In particular, in the case of a hydrous soft contact lens, since it contains water and swells, depending on the manufacturing method, if there is a large gap in the swelling rate between the colored opaque portion and the contact lens body, it may be a factor of deformation. In that respect, the colored pattern as in the present invention is highly effective in avoiding the deformation factor because the colored opaque portions are separated from each other, and is suitable for coloring the hydrous soft contact lens.

The colored contact lens of the present invention has a transparent central visual region and a colored region surrounding it, like the existing color contact lens. Basically, a colored region is formed so as to color a portion that does not enter the field of view of the wearer and mask the iris color. As described above, the conventional colored region is composed of a plane, a line, a dot, or a combination thereof. In the present invention, the colored region basically forms a sea-island structure composed of a continuous transparent portion of the sea portion and a discontinuous colored opaque portion of the island portion, and enters the classification of coloring by the dots. The biggest problem in forming an iris region with dots is that the masking effect is low compared to other classifications, but the present invention overcomes this problem by having a specific design and shape, It created an appearance that looked more natural than known color contact lenses.

In the colored region of the present invention, the “continuous transparent portion of the sea portion” occupies 20% to 70% of the colored region, preferably 45% to 65%, and most preferably 50% to 60%. Therefore, the remaining part becomes “discontinuous colored opaque part of the island part”, but this sea-island structure is, for example, a state in which the island parts are partly connected or a part of the island parts are connected, and a transparent lake between them. It does not completely exclude the existence of a part (or river part). Basically, it is preferable that each colored opaque portion is an independent island, but in a region where the density of the island portion is high, they may contact or partially overlap each other.

Examples of contact with the colored opaque parts are shown in FIG. 1 and FIG. As shown in these drawings, a plurality of scale-like colored opaque objects are formed within the annular range of 1 to 3.5 mm in width, preferably 1.5 to 3.0 mm in width from the periphery of the colored region toward the center of the lens. The parts are connected to each other on the front end side and the rear end side, and are connected in a rosary manner. Such connected scale-like island portions are composed of 3 to 20, preferably 10 or less. This is because it is necessary for making the pupil appear larger at the peripheral portion of the colored region, and the colored opaque portion becomes rougher toward the center, so that it is more natural to be independent as an island portion.

As for the arrangement of the colored opaque portion, as shown in FIG. 1 and the like, the design is arranged in series, as shown in FIG. 16, or between the adjacent scales in the front row as shown in FIG. It can arrange | position so that the scale side front end side of a back row may be located. Of course, these are merely examples of arrangement and are not limited. Various arrangements such as changing the positional relationship between the front row and the rear row at random, or placing in contact with at least one of the other opaque portions existing in the front, rear, left and right can be selected as appropriate.

“Transparent part” means a visible light (380 nm to 750 nm) transmittance of 80% to 100%, which is colorless or colored and transparent. On the other hand, the transmittance of the “opaque part” is 0% to 50%, and the target of changing the iris color (for example, Japanese, Westerners, men and women) and the color of the iris to be expressed (for example, green, blue) Is appropriately adjusted. For example, for Japanese people with dark iris colors, it is preferable to set the transmittance of the colored opaque portion to approximately 0 to 30% so that the iris color to be expressed becomes clearer.

The size of the colored opaque portion of the present invention is 70 to 600 μm in the radial direction, preferably 100 to 400 μm, and 40 to 300 μm in the circumferential direction, preferably 70 to 250 μm. Further, as described above, the shape is such that each corner of the isosceles triangle is rounded and each side is appropriately curved. Then, an arc having a large curvature (tip side) formed by the isosceles part toward the center of the lens is formed, and an arc (rear end side) having a smaller curvature formed by the base part toward the outer periphery of the lens. .

Specifically, it is a colored opaque part (2) as shown in FIG. In the colored opaque portion (2) of the colored contact lens (1), the arc (3) on the rear end side has a gentle curve. The curvature of the arc (3) (the reciprocal of the radius of curvature) is within 3 times, preferably within 2 times, more preferably 0.3 to 1.5 times the reciprocal of the distance between the arc and the center of the lens. And most preferably 0.5 to 1.2 times. In general, when a colored region is formed by a plane or a line, the boundary line is likely to be clear, and when a pattern similar to a dot is employed as in the present invention, the boundary is likely to be unclear. Therefore, by forming in such an arc shape, even if each colored opaque part is not connected, the effect of making the boundary region clear can be emphasized.

Particularly, the colored opaque portion located at the outermost periphery (the farthest from the center of the lens) forms an outer contour (a line representing the outer edge) of the pupil. The shape of the rear end side of this colored opaque portion is not essential, but if it is an arc shape as described above, the effect of enhancing the contour is further enhanced, so that the pupil can be seen larger, The texture of the iris can be improved as much as or more than the expressed iris. It should be noted that shapes other than the arc as shown in FIG. 1, such as a chord (straight line) (13) (see FIGS. 7 and 8), and a shape (23) in which several points on the arc are connected by straight lines, etc. (See FIG. 10). This is because even in these shapes, if the size of the colored opaque portion is within the above range, the effect is the same as that of the arc.

On the other hand, as the shape of the rear end side of the colored opaque portion located outside the outermost periphery, the colored opaque portion other than the arc (3) as shown in FIG. 1 and the linear shape (13) shown in FIG. The shape (33) (see FIG. 9) may be used so as to wrap the tip side of the colored opaque portion present in the rear row. This is because the shape of the rear end side of the colored opaque portion that is not located on the outermost periphery does not form part of the contour of the iris. In addition, it does not necessarily exclude that the colored opaque part of the said shape is located in the outermost periphery. This is because the outline of the iris pattern can be sufficiently formed depending on the size and arrangement of the colored opaque portions.

In FIG. 1, the arc (5) on the tip side of the colored opaque portion (2) depicts a curve having a curvature (small curvature radius) larger than the curvature of the arc (3) on the rear end side. By adopting such a shape, it is easier to express as if it converges toward the center of the lens compared to conventional simple circles, ellipses, triangles, etc., making the lens wearer's iris appear more natural. Because you can. The lens is a spherical surface, and it is appropriate to make the figure drawn there more three-dimensional. However, the shape is not limited to a curve as shown in the figure, and may be a shape in which several points on an arc are connected by straight lines (see FIG. 10). Further, sub-patterns having different hues (for example, radial intermittent line patterns, etc.) may be overlapped by a known method other than the outermost periphery.

In short, the meaning of the “curvature” of “the scale of the lens having a larger curvature than the outer peripheral direction of the lens” according to the present invention may be regarded as drawing a curve macroscopically. But it doesn't have to be a curve throughout. This means that a combination of “plurality of curves” and / or “plurality of straight lines” includes what represents a curve as a whole.

It is preferable that the colored opaque portion having the above-described shape gradually decreases toward the center of the lens. Since the tip side is designed with a larger curvature than the rear end side, it can be expressed to attract people's attention to the pupil from the periphery, but the effect is further amplified by gradually decreasing the size. (See, for example, FIG. 1 and FIG. 7). In addition, since the area is naturally reduced toward the center of the lens, and more small colored opaque portions can be arranged, there is an effect that the texture of the iris can be easily changed. And since it eventually continues to the central visual area, there is a risk of damaging the natural appearance if there is a very clear change in the transition part. It is desirable that the visual area is connected.

Further, the number of colored opaque portions may be gradually decreased toward the center of the lens. In particular, when the size of each colored opaque portion is the same, it is necessary to cope with the area becoming smaller toward the center of the lens (see, for example, FIG. 8). As described above, this reduction technique is a conventionally known design, and has been naturally adopted in the dot pattern coloring method.

1 A transparent visual center lens region (7) is formed at the center of the colored contact lens (1) of the present invention illustrated in FIG. The visible light transmittance of the central visual region is equal to or greater than that of the transparent portion (9) of the colored region (8) and allows light to enter the pupil. The size is 7 to 11 mm in diameter, The thickness is preferably 7 to 10 mm. This is to ensure a sufficient field of view. The colored region (8) surrounding the central visual region (7) is formed in an annular shape with a radial width in the range of 1.0 to 3.5 mm, preferably in the range of 1.5 to 3.0 mm. Yes. In order to make the pupil appear larger, the colored region is formed so as to expand further in the lens outer peripheral direction.

Furthermore, a transparent peripheral region (10) may be provided so as to surround the colored region (8). It is appropriately formed in relation to the lens size. The visible light transmittance of the transparent peripheral region is equivalent to that of the central visual region, and is colorless or colored and transparent.

The colored contact lens of the present invention illustrated in FIG. 11 is an example in which the colored region (28) has a narrow width and the number of colored opaque portions is rapidly decreased toward the central visual region (27). This design is expressed so that the ring stands out, and has the effect of making the pupil look larger while still using the wearer's iris pattern.

FIG. 12 shows an example in which the colored regions (37) are shown to form a double ring, and colored opaque portions are dispersed therebetween. In this example, the number of colored opaque portions gradually decreases toward the central visual region (36), and again increases at the boundary with the central visual region, and is arranged in a ring shape. This design has the effect of making the eyes look patchy.

FIG. 13 shows a design in which the outline inside the colored region (38) looks jagged, and FIG. 14 shows a design in which a colored pattern (39) shows a heart-shaped pattern. These are designed to enjoy the so-called fashion rather than show them naturally.

FIG. 15 shows a design including a display (43) representing, for example, a ballast axis and a cylindrical axis necessary for a toric lens in the colored region (41). In this example, except for the case where the image is observed by a specific person such as a doctor, these displays are effectively mixed in the colored region, so that it is difficult for a third party to distinguish. This is because the information obtained from these displays need not be particularly recognized by the user or a third party.

FIG. 16 is an example in which the colored opaque portion of the colored region (48) is arranged so that the tip side of the scale shape in the rear row is located in the middle of the adjacent scale shapes in the front row. Compared to the example of linear and radial arrangement, the feeling of random arrangement is reflected in a more natural design from a third party.

As a colored contact lens of the present invention, a manufacturing method using a double-sided mold in a case where a colored portion is sandwiched between lens materials includes the following steps as shown in FIG.
(I) A monomer composition (50) for forming a contact lens is filled between a mold A that forms one surface of a contact lens and a mold B that can form a semi-finished product that is thinner than the contact lens product. The process of polymerizing.
(II) A step of removing the mold B and applying the coloring composition (52) so as to form a colored opaque portion on the exposed surface of the contact lens semi-finished product (51) and fixing it to the contact lens semi-finished product.
(III) The contact lens forming monomer composition (50) is further provided between a mold C forming the other surface of the contact lens and a mold A having a contact lens semi-finished product coated with the coloring composition. The process of filling and polymerizing.
(IV) A step of opening the mold A and the mold C and taking out the colored contact lens (61) after polymerization.

In the step (I), the mold A is preferably a mold that forms the inner surface side of the contact lens. This is because the inner surface side is a side in contact with the cornea, and it can be ensured that the colored opaque portion does not come out on the surface reliably, and at the worst it is not exposed to the cornea side. The space formed in combination with the mold B must be thinner than the actual contact lens product. This is because the colored portion is sandwiched between lens materials.

The mold B is removed in step (II), and the contact lens semi-finished product after polymerization needs to be selectively left in the mold A. In order to ensure this selectivity, the mold A and the mold B are molded with different resins, or the contact lens semi-finished product is easily adsorbed or peeled off to either the mold A or the mold B (for example, an interface). It is preferable to apply an activator or plasma treatment. Alternatively, an apparatus such as Japanese Patent No. 46579797 may be used, or heat may be applied to one mold and the mold A may be selectively left in the mold A.

In step (II), a coloring composition is applied, and various methods can be appropriately employed for this method, such as screen printing, pad printing, and ink jet printing. Which application method is selected is determined in consideration of the physical properties of the coloring composition and the lens material. There are various methods (heating, drying, electron beam irradiation, etc.) for fixing to the contact lens semi-finished product. Moreover, application | coating of the composition for coloring is not restricted to once, You may apply | coat a different color and pattern twice or more by a well-known method.

In step (III), the monomer composition for forming a contact lens is filled between a mold A and a mold C having a contact lens semi-finished product on which the coloring composition is fixed, and the coloring composition is sandwiched therebetween. Colored contact lenses are polymerized. In the method for producing a hydrous soft contact lens as a colored contact lens, the contact lens forming monomer composition contains a solvent other than the polymerizable monomer (commonly referred to as wet mold) and does not contain a solvent. There are cases (usually called dry molds). In the wet mold, since the solvent is replaced with water after hydration, the size change is small between the state after polymerization and the state after hydration, whereas the size of the dry mold is swollen after hydration. Therefore, the space of the contact lens shape formed by the mold A and the mold C must take into account the size after hydration.

In step (IV), mold A and mold C are opened, the colored contact lens after polymerization is taken out, and hydration treatment or surface hydrophilization treatment is performed as necessary. Since the present invention is an invention related to the design of a colored contact lens, the production method will be shown simply, but the polymerization temperature and time in each step, the type and composition ratio of the monomers in each composition, the colorant The type and the like are determined as appropriate.

By the way, the standard of the contact lens includes the curvature radius (BC) on the inner surface side, the center thickness (CT), the power (PW), the diameter (DIA), and the shape of the lens edge. The PW is determined by the refractive index, BC, and the radius of curvature (FC) on the outer surface side. However, the range of the radius of curvature of the cornea is as narrow as 7.5 to 8.2 mm, so the standard number of BC is determined in advance. Less than the standard number. In particular, there may be only one type of BC for a soft contact lens. Therefore, instead of using the mold A on the inner surface side in the process (I) and using the mold C in the process (III), a semi-finished product that is thicker than the contact lens product is formed. There is a so-called single-sided mold manufacturing method that uses the mold D to cut the FC side as necessary to manufacture a lens of a desired PW. Such a method has the advantage that it is not necessary to prepare a mold C for each PW in advance, it can be made to order, and inventory management is easy. Since colored contact lenses are somewhat influenced by the fashion, depending on the production scale and the number of designs, they may not be suitable for assortment as stock. In such a case, it can be considered that the single-sided mold manufacturing method is suitable.

Moreover, the manufacturing method by a double-sided mold in case a colored part appears on the surface of a lens includes the following processes, for example.
(I) The process of apply | coating the composition for coloring to the type | mold A which forms one side of a contact lens, and fixing to a type | mold surface.
(II) A step of filling and polymerizing the contact lens-forming monomer composition between the mold A and the mold C forming the other surface of the contact lens.
(III) A step of opening the mold A and the mold C and taking out the colored contact lens after polymerization.

The advantage of this method is that the number of steps and the number of molds are smaller than when the colored portion is sandwiched between lens materials. Therefore, although it is very advantageous in terms of cost, it may appear on the surface just by embedding the colored portion, so that there may be some problems in safety. Basically, the material of the colored part is a compound that has been confirmed to be safe for the eyes, so it is chemically safe, but the hardness of the lens material in the colored opaque part and the transparent part and the central visual region. This is because there is a possibility that a physical stimulus may occur because of the difference between the two. Further, there is a risk that the colored opaque part will be peeled off.

The colored contact lens of the present invention is basically manufactured by the mold polymerization method as described above. For example, after the lens is manufactured by a cutting method, the surface is formed by laser processing or the like so that a pattern with a predetermined shape is obtained. A method of fixing the colorant composition to the portion after shaving is also possible, and the method is not limited to the mold polymerization method.

Further, the colored contact lens of the present invention can be produced with non-hydrous soft contact lenses, silicone hydrogel soft contact lenses, oxygen permeable hard contact lenses, etc. in addition to the hydrous soft contact lenses as described above. However, the type of lens material is not necessarily specified.

In order to clarify the present invention more specifically, some examples will be shown below.
In addition to the design pattern shown in FIG. 1 (Example 1), the dot (20) shown in FIG. 3 (Comparative Example 1), the curve (25) shown in FIG. 4 (Comparative Example 2), and FIG. 5 (Comparative Example 3) Colored contact lenses are produced with the rod-shaped (30) shown in FIG. 6 and the ring-shaped (35) shown in FIG. 6 (Comparative Example 4), and the subject wears on one eye, and the other eye of the naked eye using a mirror. The difference in appearance was compared. Furthermore, wearing eyes were changed and both eyes were similarly evaluated.

The colored contact lens was prepared as follows.
Female B made of polypropylene (PP), monomer composition for forming contact lenses (2-hydroxyethyl methacrylate (hereinafter referred to as 2-HEMA) 59 w / w%, glycerol methacrylate (hereinafter referred to as GMA) 30 w / w%, ethylene Glycol dimethacrylate (hereinafter referred to as EDMA) 0.5 w / w%, photopolymerization initiator (2-hydroxy-2-methyl-1-phenyl-propan-1-one) 0.5 w / w%, glycerin: 10 w / w (w%) 23 μl, fitted with a plasma-treated PP male mold A, irradiated with light (wavelength: 365 nm, 1 mW / cm ² ) for 5 minutes in a nitrogen atmosphere, and contact lens forming monomer composition Was polymerized.

When the two molds were separated, the contact lens semi-finished product adhered to the male mold A due to the effect of the plasma treatment of the male mold A. The male mold A and the female mold B are semi-contact lens products having a front surface radius of curvature of 6.6 mm, a rear surface radius of curvature of 6.6 mm, a center thickness of 0.024 mm, and an outer diameter of 10.92 mm in a space where both molds are combined. It is supposed to be formed.

In order to make the exposed surface of the contact lens semi-finished product into the design pattern of FIG. 1, a colorant composition (2-HEMA: 30 w / w%, iron oxide: 40 w / w%, titanium oxide: 20 w / w%, thickening) The agent (polyvinylpyrrolidone): 10 w / w%) was pad-printed to a thickness of 10 μm and left in a blower at about 25 ° C. for 10 minutes. The surface of the applied colorant composition was fixed to be dry.

A PP female model C was filled with 35 μl of the monomer composition for forming a contact lens, and left in a blower to be fitted with a male mold A to which a contact lens semi-finished product fixed with a colorant composition was attached. In a nitrogen atmosphere, light (wavelength: 365 nm, 3 mW / cm ² ) was irradiated for 5 minutes. By this irradiation, the monomer composition for forming a contact lens was polymerized. Next, when the female mold C and the male mold A were separated, the polymer was attached to the male mold A.

When the male mold A to which the polymer was adhered was immersed in 5 ml of purified water, the polymer was swollen and removed from the mold A. The polymer swollen in 5 ml of fresh purified water was immersed for 10 minutes at room temperature. The exchange of the purified water was repeated 5 times to remove the eluting component in the polymer. Next, the polymer is placed in a PP container containing 1 ml of purified water containing 0.9 w / v% sodium chloride and 0.03 w / v% ethylenediaminetetraacetic acid trisodium salt, and sealed with a multilayer film at 121 ° C. Autoclaved for 20 minutes. After cooling, the multilayer film was peeled off and the polymer was inspected. A colored contact lens having PW: −3.00D, CT: 0.11 mm, diameter: 14.2 mm, and the scale pattern of FIG. 1 formed inside the lens was obtained. This lens is formed in an annular shape with a central visual region diameter of 8.0 mm and a colored region having a radial width of 2.5 mm.

For the designs of Comparative Examples 1 to 4, colored regions were formed by the same manufacturing method as described above. Each of these five types of colored contact lenses was worn on one eye, and the wearer observed his / her eyes with a mirror, and compared with the other eyes of the naked eye whether the pupils looked larger naturally. Comparison was made 15 minutes after wearing in the room. The wearing eyes were changed, and both eyes were confirmed in the same manner. Needless to say, before wearing each contact lens, chemical analysis such as elution test, various tests such as cytotoxicity test and rabbit eyewear test are performed to ensure sufficient safety. did.

The evaluation criteria by the subjects are:
Evaluation point 2: Black eyes appear to be naturally enlarged (as if no colored lens is worn).
Evaluation point 1: The dark pupil is somewhat unnatural (sometimes wearing a colored lens), but appears to be larger.
Evaluation point 0: The dark pupil does not appear to be unnatural (like wearing a colored lens) or enlarged.
It was. The results are shown in Table 1.

From the results in Table 1, the following can be said.
The scale pattern of FIG. 1 used in Example 1 looked large naturally.
On the other hand, the dot pattern of FIG. 3 used in Comparative Example 1 was a slightly unnatural boundary in which the dark black and white of the white of the dot pattern were mixed at the boundary with the white eye, and looked somewhat unnatural. In the curve pattern of FIG. 4 used in Comparative Example 2, the boundary with the white eye looked natural, but the difference in contrast between the dark black on the center side of the lens and the black on the iris was clear, and the colored contact lens It gave me a feeling of wearing and was unnatural. The rod and spoke pattern of FIG. 5 used in Comparative Example 3 has a clear boundary in which a straight rod and a dark black and white color of the spoke pattern are mixed deeply into the boundary with the white eye. It looked natural. The ring pattern of FIG. 6 used in Comparative Example 4 looked natural at the boundary with the white eye, but the difference in contrast between the dark black on the center side of the lens and the black of the iris was clear, and a colored contact lens was worn. It gave me a feeling of being unnatural.

Each colored contact lens was prepared in the same manner as in Example 1 except that the design pattern in FIG. 1 was changed to the design shown in FIGS. Each of the designs in FIGS. 7 to 10 is an example in which the curvature on the rear end side is variously changed in the shape of the colored opaque portion, and is linear (13) (FIGS. 7 and 8) toward the center of the lens. A curved shape (33) (FIG. 9) and a shape (23) (FIG. 10) in which two points on a circular arc are connected by a straight line. Note that FIG. 7 is different from FIG. 8 in that FIG. 7 is an example in which the size of the colored opaque portion gradually decreases toward the center of the lens, whereas FIG. 8 does not change the size. For each of these lenses, the same evaluation test as in Example 1 was performed. The results are shown in Table 2.

As shown in Table 2, it was found that the colored contact lens according to the present invention has a large pupil and looks natural.

In the same manner as in Example 1, the PP female mold C and male mold A were fitted and polymerized. Female mold C was filled with 60 μl of the monomer composition for contact lens formation. The polymer formed in the female mold C was designed to be thicker than the lens of Example 1. When the female mold C and the male mold A were separated, the polymer was attached to the male mold A. This female mold was fixed to the shaft of a contact lens manufacturing lathe, rotated at 300 RPM, and the polymer was cut with a diamond blade to finish into a contact lens shape. In the same manner as in Example 1, the male mold A with the polymer finished in the contact lens shape was immersed in 5 ml of purified water, the same treatment was performed, and the polymer was inspected. A colored contact lens having PW: −3.00D, CT: 0.11 mm, diameter: 14.2 mm, and the scale pattern of FIG. 1 formed inside the lens was obtained.

The present invention introduces new equipment because a colored contact lens having a pattern that gives a very natural appearance and can change the apparent color of the wearer's pupil can be manufactured by extension of the prior art. In addition, it can meet a wide range of consumer needs without reducing the cost increase.

DESCRIPTION OF

SYMBOLS

1, 61 ... Colored contact lens 2 ... Colored

opaque part

7, 27, 36 ... Central

visual region

8, 28, 37, 38, 39, 41, 48 ... Colored region 10 ... Transparent periphery Area 50: Contact lens forming monomer composition 51: Contact lens semi-finished product

Claims

A colored contact lens having a transparent central visual region and a colored region surrounding it;
The colored region basically forms a sea island structure composed of a continuous transparent portion of the sea portion and a discontinuous colored opaque portion of the island portion,
A colored contact lens, wherein the colored opaque portion has a scale-like shape and has a size of 70 to 600 μm in the radial direction of the lens and 40 to 300 μm in the circumferential direction of the lens.
2. The colored contact lens according to claim 1, wherein the scale shape of the colored opaque portion is arranged toward the center of the lens and has a larger curvature in the center direction of the lens than in the outer peripheral direction of the lens.
The colored contact lens according to claim 1, wherein the size of the colored opaque portion gradually decreases toward the center of the lens.
The colored contact lens according to claim 1, wherein the number of the colored opaque portions gradually decreases toward the center of the lens.
The colored contact lens according to any one of claims 1 to 4, wherein a diameter of the central visual region is 7 to 11 mm.
A plurality of the colored opaque portions are connected to each other in the center direction of the lens and the outer peripheral direction of the lens within an annular range having a width of 1 to 3.5 mm from the periphery of the colored region toward the center direction of the lens. The colored contact lens in any one of Claims 1 thru | or 5.
The colored contact lens according to claim 1, further comprising a transparent peripheral region surrounding the colored region.