AU2754701A

AU2754701A - Colored contact lens with a more natural appearance

Info

Publication number: AU2754701A
Application number: AU27547/01A
Authority: AU
Inventors: Gerardo J. Ocampo
Original assignee: Wesley Jessen Inc
Current assignee: Novartis AG
Priority date: 2000-01-03
Filing date: 2001-01-02
Publication date: 2001-07-16
Also published as: BR0107397A; NO20023192D0; CA2393048A1; AU2754801A; EP1247136A1; NO20023217D0; EP1247135A4; WO2001050182A1; EP1247136A4; CN1394290A; CN1394292A; BR0107415A; KR20020064982A; MXPA02006642A; NO20023217L; EP1244933A4; AU2624001A; EP1244933A1; JP2003532911A; WO2001050183A1

Description

WO 01/50183 PCT/USO1/00067 -1 COLORED CONTACT LENS WITH A MORE NATURAL APPEARANCE RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. § 119(e) of the filing 5 date of the provisional U.S. patent application having serial number 60/174,288, filed on January 3, 2000, which is hereby incorporated by reference. TECHNICAL FIELD The present invention relates to colored contact lenses and in 10 particular to such lenses having multiple opaque colored portions that form a pattern that can change the apparent color of the iris while imparting a very natural appearance. BACKGROUND OF THE INVENTION Early attempts to modify or enhance the color of one's eyes utilized 15 colored contact lenses with a simple solidly colored area that covered the iris portion of the eye. However, contact lenses with this type of opaque coloring imparted a very unnatural appearance. Other types of colored contact lenses were developed, such as Wichterle, U.S. Pat. No. 3,679,504, which discloses an opaque lens having an iris of more than a 20 single color artistically drawn or photographically reproduced. However, such lenses did not look natural and as such never achieved commercial success. Other attempts to produce an opaque lens with a natural appearance are disclosed in. U.S. Pat. Nos. 3,536,386, (Spivak); 3,712,718 (LeGrand), 4,460,523 (Neefe), 4,719,657 (Bawa), 4,744,647 25 (Meshel et al.), 4,634,449 (Jenkins); European Patent Publication No. 0 309 154 (Allergan) and U.K. Patent Application No. 2 202 540 A (IGEL). Commercial success was achieved by the colored contact lens described in Knapp (in U.S. Pat. No. 4,582,402) which discloses a contact lens having, in its preferred embodiment, colored, opaque dots. The 30 Knapp lens provides a natural appearance with a lens that is simple and WO 01/50183 PCT/USO1/00067 -2 inexpensive to produce, using a simple one-color printed dot pattern. Although the intermittent pattern of dots does not fully cover the iris, it provides a sufficient density of dots that a masking effect gives the appearance of a continuous color when viewed by an ordinary observer. 5 Knapp also discloses that the printing step may be repeated one or more times using different patterns in different colors, since upon close examination the iris is found to contain more than one color. The printed pattern need not be absolutely uniform, allowing for enhancement of the fine structure of the iris. The one-color Knapp lenses currently achieving 10 commercial success have their dots arranged in an irregular pattern to enhance the structure of the iris. However, neither the Knapp commercial lenses, nor the Knapp patent disclose or suggest how one would arrange a pattern of dots having more than one color to achieve a more natural appearance. 15 Various efforts have been made to improve on the Knapp lens. U.S. Patent No. 5,414,477 to Jahnke discloses the application of the intermittent ink pattern in two or more portions of distinct shades of colorant to provide a more natural appearance. Other attempts to create a more natural appearing lens include U.S. 20 Patent No. 5,120,121 to Rawlings, which discloses a cluster of interconnecting lines radiating from the periphery of the pupil portion to the periphery of the iris portion. Further, European Patent No. 0 472 496 A2 shows a contact lens having a pattern of lines that attempts to replicate the lines found in the iris. 25 Despite these efforts, the contact lens industry continues to seek a low-cost, colored lens that can enhance or modify the eye color, while providing the depth and texture that is inherent in the human iris. SUMMARY OF THE INVENTION The present invention is based on the surprising discovery that a 30 pattern having multiple-color opaque portions can achieve a more natural WO 01/50183 PCT/USO1/00067 -3 appearing iris if configured properly. The improvement in appearance over the one-color Knapp lenses and the multiple-color Jahnke lenses is startling. Like the one and two color lenses, the lenses of this invention are able to cause a fundamental change in the apparent color of the 5 wearer's iris, e.g. from dark brown to light blue or green. Although a preferred embodiment of the invention is a three color lens wherein different colors overlap, more than three colors are contemplated, and lenses wherein all three (or more) of the different colors overlap are also contemplated. 10 One objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section. The elements of the pattern are indiscernible to the ordinary viewer and are made up of a first portion of the elements of the pattern, which is a first 15 shade, and a second portion of the elements of the pattern, which is a second shade different from said first shade, and a third portion of the elements of the pattern, which is a third shade different from said second shade and either different or the same as the first shade. Each of the three portions contain overlapping, mixing and blending elements 20 consisting of or making up, uniform and non-uniform dots, islands of colors, worms, starbursts, corkscrews, spokes, spikes, striations, radial stripes, zig-zags and/or streaks, in combination or separately. Further, each of the overlapping portions may or may not extend from one end of the non-opaque pupil section to the periphery of the iris section. The 25 blending of these various portions creates a lens capable of changing the apparent color of the iris of a person wearing the lens, while imparting a very natural appearance. Another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil 30 section, and a colored, opaque intermittent pattern over the iris section. The elements of the pattern are indiscernible to the ordinary viewer and WO 01/50183 PCT/USO1/00067 -4 are made up of a first portion of the elements of the pattern, or the outermost starburst, which is a first shade, and a second portion of the elements of the pattern, or the outer starburst, which is a second shade different from said first shade, and a third portion of the elements of the 5 pattern, or the inner starburst, which is a third shade different from said second shade and either different or the same as the first shade. The outermost starburst has a greatest concentration of elements located generally outside of the outer starburst, and the outer starburst has a greatest concentration of elements located generally outside the inner 10 starburst. A first uneven border differentiates the outermost and outer starbursts, although there is overlap of the outermost and outer starbursts. A second uneven border differentiates the outer and inner starbursts, although there is overlap between the outer and inner starbursts. Thus, a lens capable of changing the apparent color of the iris of a person wearing 15 the lens and imparting a very natural appearance is provided. Another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non 20 opaque. The pattern covers at least about 25 percent of the area of the iris section. The elements of the pattern are indiscernible to the ordinary viewer. A first portion of the elements of the pattern, or the outermost starburst, is of a first shade, and a second portion of the elements of the pattern, or the outer starburst, is of a second shade different from said first 25 shade, and a third portion of the elements of the pattern, or the inner starburst, is of a third shade different from said second shade and either different or the same as the first shade. The outermost starburst has a greatest concentration of elements located generally outside of the outer starburst, and the outer starburst has a greatest concentration of elements 30 located generally outside of the inner starburst. A first uneven border differentiates the outermost and outer starbursts although the outermost WO 01/50183 PCT/USO1/00067 -5 and outer starbursts overlap, and a second uneven border differentiates the outer and inner starbursts although the outer and inner starbursts overlap. The minimum distance of the first uneven border from the outer perimeter of said iris section is from about 5% to about 60% of the radial 5 width of said iris section. The maximum distance of the first uneven border from the outer perimeter of said iris section is from about 25% to about 95% of the radial width of the iris section. The minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 75% of the radial width of the iris section, and the 10 maximum distance of said second uneven border from the outer perimeter of the iris section is from about 50% to about 95% of the radial width of the iris section. Thus, a contact lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance is provided. 15 Another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non opaque. The pattern covers at least about 25 percent of the area of the iris 20 section. The elements of the pattern are indiscernible to the ordinary viewer. A first portion of the elements of the pattern, or the outermost starburst, is of a first shade, and a second portion of the elements of the pattern, or the outer starburst, is of a second shade different from said first shade, and a third portion of the elements of the pattern, or the inner 25 starburst, is of a third shade different from said second shade and either different or the same as the first shade. The outermost starburst has a greatest concentration of elements located generally outside of the outer starburst, and the outer starburst has a greatest concentration of elements located generally on the outside of the inner starburst. A first uneven 30 border differentiates the outermost and outer starbursts although the outermost and outer starbursts overlap, and a second uneven border WO 01/50183 PCT/USO1/00067 -6 differentiates the outer and inner starbursts although the outer and inner starbursts overlap. The minimum distance of the first uneven border from the outer perimeter of said iris section is from about 15% to about 50% of the radial width of said iris section. The maximum distance of the first 5 uneven border from the outer perimeter of said iris section is from about 45% to about 95% of the radial width of the iris section. The minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 65% of the radial width of the iris section, and the maximum distance of said second uneven border from the 10 outer perimeter of the iris section is from about 60% to about 95% of the radial width of the iris section. Thus, a contact lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance is provided. Yet another objective of the invention is to provide a colored contact 15 lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non-opaque. The pattern covers an effective amount of the iris section to change the apparent color of the iris. The pattern is made up of multiple portions, each of 20 which is a different shade from the other portion. These portions may or may not overlap each other at multiple points. At least one of the multiple portions is a design that contains either uniform or non-uniform dots, islands of color, worms, starbursts, spokes, spikes, striations, radial stripes, zig-zags and/or streaks, or some other design that, along with the other portions, provides a 25 lens capable of changing the apparent color of the iris of the person wearing the lens, while imparting a very natural appearance. Yet another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil section, and a colored, opaque intermittent pattern over the iris section, which 30 leaves a substantial portion within the interstices of the pattern non-opaque. The pattern, which is made up of elements, covers an effective amount of the iris section to change the apparent color of the iris. The pattern is made up of WO 01/50183 PCT/USO1/00067 -7 multiple portions, each of which is a different shade from the other portion. Further, one of these portions is the darkest shade, one of these portions is the lightest shade, and the pattern is configured so that the darkest shaded portion has the greatest concentration of elements located generally outside 5 the other portions. This design provides a lens capable of changing the apparent color of the iris of the person wearing the lens, while imparting a very natural appearance. Yet another objective of the invention is to provide a colored contact lens with a non-opaque pupil section, an iris section surrounding the pupil 10 section, and a colored, opaque intermittent pattern over the iris section, which leaves a substantial portion within the interstices of the pattern non-opaque. The pattern, which is made up of elements, covers an effective amount of the iris section to change the apparent color of the iris. The pattern is made up of at least three portions, each of which is a different shade from each other 15 portion. Each of the portions overlap the other portion at multiple points. These overlapping portions blend, mix or commingle together, or appear to blend, mix or commingle together, producing unique textures, colors and patterns that make the eye look natural when the contact lens is placed on the eye. To obtain the commingling or blending of the portions, in some instances 20 the different shades will be printed in the same location or close enough that the difference in location is not discernible. This design provides a lens capable of changing the apparent color of the iris of a person wearing the lens, while imparting a very natural appearance. It can be easily understood that other colored lenses having patterns 25 with multiple portions (having different shades or colors) can be designed and still fall within the scope of the present invention. The term "non-opaque" as used herein is intended to describe a part of the lens that is uncolored or colored with translucent coloring. The term "second shade different from said first shade" (or some 30 similar language) as used herein is intended to mean that both shades are of totally different colors, such as blue and hazel; or that both shades are WO 01/50183 PCT/USO1/00067 -8 the same basic color, but having different intensities such as light blue and dark blue. The term "ordinary viewer" is intended to mean a person having normal 20-20 vision standing about 5 feet from a person wearing the 5 lenses of this invention. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a contact lens pattern in accordance with the present invention; Figure 2 illustrates a contact lens pattern indicating an outermost 10 starburst in accordance with the present invention; Figure 3 illustrates a contact lens pattern indicating an outer starburst in accordance with the present invention; Figure 4 illustrates a contact lens pattern indicating an inner starburst in accordance with the present invention; 15 Figures 5A-5C illustrate three contact lens patterns in accordance with the present invention; Figure 6 illustrates a contact lens design based on the combination of Figures 5A-5C in accordance with the present invention; Figure 7 illustrates a contact lens pattern with elements removed 20 from the periphery of the pattern in accordance with the present invention; Figure 8 illustrates a contact lens pattern that is not substantially continuous in accordance with the present invention; Figure 9 illustrates three contact lens patterns, one of which is not substantially continuous in accordance with the present invention; 25 Figure 10 illustrates three contact lens patterns in accordance with the present invention; Figure 11 illustrates three contact lens patterns in accordance with the present invention; Figure 12 illustrates three contact lens patterns and the combined 30 contact lens design in accordance with the present invention; WO 01/50183 PCT/USO1/00067 -9 Figure 13 illustrates three contact lens patterns and the combined contact lens design in accordance with the present invention; Figure 14 illustrates three contact lens patterns and the combined contact lens design in accordance with the present invention; 5 Figure 15 illustrates a three-pattern contact lens design in accordance with the present invention; Figure 16 illustrates a three-pattern contact lens design in accordance with the present invention; Figure 17 illustrates a three-pattern contact lens design in 10 accordance with the present invention; Figure 18 illustrates a three-pattern contact lens design in accordance with the present invention; Figure 19 illustrates a four-pattern contact lens design in accordance with the present invention; 15 Figure 20 illustrates a three-pattern contact lens design in accordance with the present invention; Figure 21 illustrates a four-pattern contact lens design in accordance with the present invention; and Figure 22 illustrates a four-pattern contact lens design in accordance 20 with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Figure 1 shows a contact lens 10 in accordance with the present invention. It has a non-opaque pupil section 20 in the center of lens, and an annular iris section 22 surrounding the pupil section. For hydrophilic 25 lenses a peripheral section (not shown) surrounds iris section 22. A colored, opaque, intermittent pattern is located over the iris section 22, as show in Figure 1. The pattern leaves a substantial portion of the iris section within the interstices of the pattern non-opaque. The non-opaque areas of the iris section 22 appear white in Figure 1.

WO 01/50183 PCT/USO1/00067 -10 The elements of the pattern are preferably dots, and especially preferred are dots, some of which run together, as shown in Figure 1. Certain portions of the iris section 22 are less densely covered with dots than other portions. 5 The opaque pattern or patterns can be made up of dots having regular or irregular, uniform or non-uniform shapes, for example, round, square, hexagonal, elongated, or other dot shapes. Further, the elements of the pattern may have a shape other than dots, so long as the elements are undescrinable to the ordinary viewer, cover between 10 and 30 10 percent, preferably about 20 percent of the iris, and leave a substantial portion of the iris section within the interstices of the pattern non-opaque. The patterns that make up the portions of the iris can be islands of color or worms, corkscrews, starbursts, spokes, spikes, striations, radial stripes, zig-zags and streaks. In certain cases, a single color background is used 15 to complement the multi-pattern design. These patterns blend with each other to provide a colored contact lens that enhances the structure of the iris of a person wearing the lens. The improvement of this invention is a multiple color pattern that greatly improves the natural appearance of the wearer's iris, even over that 20 of one and two color lenses. To produce this improvement, three (or more) colored patterns are printed in three or more portions. A first portion of the elements are of a first shade and generally have a greatest concentration of dots or other elements located generally on the outside of, but within, the iris section, i.e. at or near the outer perimeter of the annular iris 25 section. This section may be referred to as the outermost starburst. A preferable first outside portion pattern or outermost starburst is shown in Figure 2. Black, or some other dark color such as gray, dark-brown or dark blue, is most often used as the color of the outermost starburst. A second portion (the outer starburst) of the elements are a second 30 shade, which is different from the first shade, and has elements with a greatest concentration located generally on the inside of the outermost WO 01/50183 PCT/USO1/00067 -11 starburst, and generally, although not always, surrounded by the outermost starburst portion. A preferable second portion or outer starburst appears in Figure 3. The outer starburst can be many colors, for example, blue, gray, brown, light blue, turquoise, violet, blue-violet, aqua, yellow or green. 5 A third portion (the inner starburst) of the elements are of a third shade, which is different from the second shade and either the same or different from the first shade. This third portion has a greatest concentration of elements located generally, but not always, on the inside of the other two portions. Generally, the greatest concentration of 10 elements of the third portion is surrounded by the concentration of elements of the other two portions. A preferable third inside portion pattern or inner starburst appears in Figure 4. A preferred color for the inner starburst is hazel, but other colors to be used include yellow, yellow-green, brown, yellow-brown, gold and orange. Figure 1, a preferred embodiment 15 of the present invention, shows a combination of Figures 2, 3 and 4. In a preferred embodiment, a first uneven border differentiates the outermost starburst and the outer starburst portions of the pattern elements, however, the elements of the outermost and outer starbursts overlap, mix and blend together, either in actuality or merely in perception, 20 to create the desired effect. A second uneven border differentiates the outer starburst and the inner starburst portions of the pattern. The elements of the outer and inner starbursts overlap, mix and blend together, either in actuality or in perception. If the patterns of Figures 2, 3 and 4 are merged to form a three color lens, the uneven edge of the pattern shown in 25 Figure 2 will merge and overlap with the pattern shown in Figure 3 to form the first uneven border between the outermost and outer starbursts. Further, the uneven edge of the pattern shown in Figure 4 will merge and overlap with the pattern shown in Figure 3 to form the second uneven border between the outer and inner starbursts. 30 In certain patterns, the outer starburst may contain pattern that extends further toward the periphery of the lens than the pattern of the WO 01/50183 PCT/USO1/00067 -12 outermost starburst. In other patterns, the outer starburst may contain pattern that extends further toward the pupil section of the lens than the pattern of the inner starburst. Alternative embodiments of the present invention include minimum and 5 maximum distances of the uneven borders from the outer perimeter of the iris section. For example in one alternative embodiment, the minimum distance of the first uneven border from the outer perimeter of the iris section is from about 5% to about 60% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris 10 section is from about 25% to about 95% of the radial width of the iris section, and the minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 75% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris section is from about 50% to about 95% of the 15 radial width of the iris section. In another embodiment, the minimum distance of the first uneven border from the outer perimeter of the iris section is from about 15% to about 50% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris section is from about 45% 20 to about 95% of the radial width of the iris section, and the minimum distance of the second uneven border from the outer perimeter of the iris section is from about 15% to about 65% of the radial width of the iris section, and the maximum distance of the uneven border from the outer perimeter of the iris section is from about 60% to about 95% of the radial width of the iris section. 25 In yet another alternative embodiment, the outer starburst pattern may extend to the periphery of the iris section of the contact lens, such that some elements that make up the outer starburst are outside of all of the elements that make up the outermost starburst pattern, and/or the elements that make up the outer starburst pattern extend closer to the pupil 30 section such that some of those elements are inside all of the elements of the inner starburst pattern.

WO 01/50183 PCT/USO1/00067 -13 In yet another alternative embodiment, the inner starburst pattern creates an interdigitation configuration with either the outermost starburst pattern or the outer starburst pattern or both patterns. Further, the outermost starburst pattern may create an interdigitation configuration with 5 the outer starburst pattern. In an interdigitation configuration, one pattern intersects another similar to the fingers on one hand placed between the fingers on the other hand in a planar fashion. Another embodiment is made up of a pattern in which at least one of the portions, and preferably more than one, is made up of a pattern or 10 design which consists of elements which are or create uniform and non uniform dots, islands of color, worms, corkscrews, starbursts, spokes, spikes, striations, radial stripes, zig-zags and/or streaks (see the examples in Figures 5-22). Also, a single color may be used as a background in conjunction with the multi-pattern design (see Figures 21 and 22). In these 15 designs the portions may be the same, as in Figures 15 and 16, or different, as in Figures 19, 20 and 21. For example, if the outermost starburst is the same as that of Figure 2, and the outer starburst is the one shown in Figure 3, then the inner starburst may be a design in which radial stripes begin at the inner portion of the iris and travel in a radial direction 20 toward the outer periphery of the iris. In this particular embodiment, the remaining multiple portions, whether there are two or more, are made up of a plurality of elements, which may be similar in design to the foregoing portion, combine to leave a substantial portion within the interstices of the pattern non-opaque. 25 Alternative embodiments include patterns designed such that the greatest concentration of elements having the darkest color or shaded portion are located generally on the outside of the concentration of the elements of the other portions. In particular, the darkest shaded portion has a greater concentration of elements generally located outside the 30 portions with the lighter shaded portions. Another embodiment places the different portions having different shades such that the darkest portion has WO 01/50183 PCT/USO1/00067 -14 the greatest concentration of elements generally located on the outside of the other portions, and the next darkest portion has the greatest concentration of elements generally located outside the remaining portions' elements. This design continues until the lightest shaded portion has the 5 greatest concentration of elements generally located inside all of the other portions. Another embodiment includes patterns that are not continuous or concentric. In other words, these patterns, which may be of the type listed above, have noticeable non-opaque areas such that when viewed without 10 the other patterns, the non-opaque areas are clearly visible. However, when these patterns are combined with other patterns, the overlapping, blending and mixing of these patterns creates a design that is able to change the apparent color of the iris, while imparting a very natural appearance. 15 Producing the opaque portions of the iris section is preferably accomplished by printing the lens three times using the known printing process of Knapp's U.S. Pat. No. 4,582,402, incorporated herein by reference, and the known printing process of Rawlings' U.S. Patent Nos. 5,034,166 and 5,116,112, incorporated herein by reference. Generally, a 20 plate or cliche having depressions in the desired pattern is smeared with ink of the desired shade. Excess ink is removed by scrapping the surface of the plate with a doctor blade leaving the depression filled with ink. A silicon rubber pad is pressed against the plate to pick up the ink from the depressions and then is pressed against a surface of the lens to transfer 25 the pattern to the lens. The printed pattern is then cured to render it unremovable from the lens. Of course, either the anterior or posterior surfaces of the lens may be printed, but printing the anterior surface is presently preferred. Preferred lenses and ink ingredients used to practice this invention 30 are known and described in Loshaek's U.S. Pat. No. 4,668,240, incorporated herein by reference. The specific ingredients and target WO 01/50183 PCT/USO1/00067 -15 weights are described in detail below. Very briefly, a lens constructured of polymer having -COOH, -OH, or -NH 2 groups is printed with ink containing binding polymer having the same functional groups, opaque coloring substance, and a diisocyanate compound. First a solution of binding 5 polymer and solvent is prepared and this solution is mixed with paste containing the coloring substance to form an ink. A preferred binding polymer solutions have a viscosity of about 35,000 CPS for blue, gray, brown and black, and 50,000 CPS for green. The opaque ink is printed and cured on the lens surface. 10 Ink pastes and pigments that can be utilized in the present invention can be made in a number of different ways using the ingredients and percentages (by weight) as described below in the ink color charts. For example, a hazel ink paste can be made using 63.49 percent binder solution (by weight), 30.00 percent ethyl lactate, 0.61 percent titanium dioxide, 0.06 15 percent PCN blue, 4.30 percent iron oxide yellow, and 1.54 percent iron oxide red. Although these colors are used for the preferred embodiments, other colors or variations of the weight percentage of ingredients may be used. The charts below are merely a representative example of the possible inks and pigment levels, and is not a complete list. One of ordinary skill in the art could 20 develop other inks and pigment levels that would provide an enhancing effect to the iris of a person wearing the contact lens. INK PASTE COLOR CODE BLUE GRAY Total Wt. (g) 600 3000 600 3000 Ingredient Weight Target Target Weight Target Target Percent Weight Weight Percent Weight Weight Ethyl Lactate 30.55 183.30 916.50 30.75 184.50 922.50 Binder SoIn 61.15 366.90 1834.50 59.84 359.10 1795.50 PCN Blue 1.21 7.26 36.30 PCN Green 0.23 1.38 6.90 TiO 2 7.09 42.54 212.70 7.34 44.04 220.20 10 Black 1.83 10.98 54.90 Grinding Media 600 3000 600 3000 WO 01/50183 PCT/USO1/00067 -16 INK PASTE COLOR BROWN HAZEL Total Wt. (g) 651 3000 651 3000 Ingredient Weight Target Target Weight Target Target Percent Weight Weight Percent Weight Weight Ethyl Lactate 30.00 180.00 900.00 30.00 180.00 900.00 Binder Soln 55.10 330.60 1653.00 63.49 380.94 1904.70 PCN Blue 0.06 0.36 1.80 TiO 2 0.61 3.65 18.3 10 Black 5.70 34.20 171.00 10 Red 3.45 20.70 103.50 1.54 9.25 46.20 10 Yellow 4.30 25.80 129.00 10 Brown 5.75 34.50 172.50 Grinding Media 600 3000 600 3000 INK PASTE COLOR GREEN BLACK Total Wt. (g) 651 3000 651 3000 Ingredient Weight Target Target Weight Target Target Percent Weight Weight Percent Weight Weight Ethyl Lactate 28.53 185.73 855.90 23.98 156.11 719.40 Binder Soln 63.85 415.66 1915.50 64.04 416.90 1921.20 PCN Blue 0.03 0.20 0.90 1O Black 11.98 77.99 359.4 Cr203 7.59 49.41 227.70 Grinding Media 850 4298 850 4298 INK PASTE COLOR TURQUOISE ORANGE Total Wt. (g) 600 3000 600 3000 Ingredient Weight Target Target Weight Target Target Percent Weight Weight Percent Weight Weight Ethyl Lactate 30.00 180.00 900.00 30.00 180.00 900.00 Binder Soln 58.16 348.96 1744.80 58.00 348.00 1740.00 PCN Blue 0.63 3.78 18.90 PCN Green 2.25 13.50 67.50 TiO 2 8.88 53.28 266.40 10 Red 6.00 36.00 180.00 Carbazole Violet 0.08 0.48 2.40 Hydrophobic 10 6.00 36.00 180.00 Grinding Media 600.00 5000.00 850.00 4298.00 5 Of course, alternative ways to form colored opaque elements of the lens may be used. For example, selected portions of the iris section of a wetted hydrophilic lens may be impregnated with a solution of a first substance, such as barium chloride. Then the lens may be immersed in a solution of a second substance, such as sulfuric acid, that forms an opaque, 10 water-insoluble precipitate with the first substance, for example barium WO 01/50183 PCT/USO1/00067 -17 sulfate. Thus an opaque precipitate forms within the lens in a predetermined pattern in the iris section. Next all or at least the opaque pattern of the iris section is colored opaque pattern in accordance with the invention. If the entire iris is colored with translucent tint, then the interstices within the pattern 5 will be translucently colored, but still non-opaque and in accordance with a preferred embodiment of the present invention. Optionally, the pupil section of the lens may be colored by a non-opaque tint, because such tint is not visible when the lens is against the dark pupil present in the eye of the wearer. Other alternative opaquing methods include use of a laser (U.S. Pat. 10 No. 4,744,647) and finely ground particles U.S. Pat. No. 4,460,523. The process of the present invention for making colored contact lenses is as follows. A transparent contact lens comprising at least a pupil section and an iris section surrounding the pupil section is provided. If the lens is constructed of a hydrophilic material, it also has a 15 peripheral section surrounding iris section. For hydrophilic material, the steps described below are performed with the material in an unhydrated state. Preferred hydrophilic materials are disclosed by Loshaek in U.S. Pat. No. 4,405,773, incorporated herein by reference. The colored pattern may be deposited onto iris section of the lens in 20 any manner. A currently preferred method is by offset pad printing, described below in some detail. A plate as (not shown) is prepared having a flat surface and circular depressions corresponding to the desired dot pattern. To make the pattern shown in Figures 2, 3 and 4, each depression should have a diameter of 25 approximately 0.1 mm, and a depth of approximately 0.013 mm. The depressions are arranged to cover an annular shape corresponding to that of the iris section of the lens. The plate may be made by a technique that is well known for making integrated analog or digital circuits. First, a pattern about 20 times as large 30 as the desired pattern is prepared. Next, the pattern is reduced using well known photographic techniques to a pattern of the exact desired size WO 01/50183 PCT/USO1/00067 -18 having the portion to be colored darker than the remaining area. A flat surface is covered by a photo resist material that becomes water insoluble when exposed to light. The photo resist material is covered with the pattern and exposed to light. The portion of the photo resist pattern is 5 removed by washing with water and the resulting plate is etched to the required depth. Then the remainder of the photo resist material is mechanically removed. Colorant, comprising a pigment and binder or carrier for the pigment is deposited on the flat surface of the plate and scraped across the pattern 10 with a doctor blade. This causes the depressions to be filled with ink while removing excess ink from flat surface. The colorant may be more or less opaque depending on the degree of color change desired. The opacity may be varied by modifying the proportion of pigment to binder in the colorant. A desired affect may be obtained using a highly opaque colorant 15 or by having a somewhat less opaque colorant and covering a greater portion of the iris section surface. A pad made of silicon rubber, impregnated with silicon oil for easy release, is pressed against the pattern, removing ink from the depressions. The ink on the pad is allowed to dry slightly to improve tackiness, then 20 pressed against the front surface of the contact lens, which deposits the ink in the desired pattern over the iris section. The pad should have enough flexibility to deform to fit over the convex front surface of the lens. For a more natural effect, the printing step may be repeated one or more times using different patterns in different colors, since upon close 25 examination, the iris's of many persons are found to contain more than one color. The printed pattern need not be absolutely uniform, allowing for enhancement of the fine structure of the iris. Next the deposited pattern is treated to render it resistant to removal from the lens under exposure to the ocular fluids that the lens will encounter 30 when placed in the eye. The exact method of preventing removal depends on the material of construction of the lens and the pattern. Mere air drying or WO 01/50183 PCT/USO1/00067 -19 heating the lens may suffice. For hydrophilic lenses, the techniques for coating the opaque pattern described in Wichterle, U.S. Pat. No. 3,679,504 (incorporated herein by reference), may be used. The method for manufacturing a colored contact lens generally 5 includes the steps of applying three portions of colorant to the surface of a transparent contact lens and rendering the colorant resistant to removal from ocular fluids. The printed contact lens has a non-opaque pupil section and an iris section surrounding said pupil section with the three portions of colorant. The first portion of colorant, or outermost starburst, is of a first shade, the 10 second portion of colorant, the outer starburst, is a second shade which is different from the first shade, and the third portion of the colorant, or the inner starburst, is a third shade which is different from the second shade and may or may not be the same as the first shade. The outermost starburst may be located such that the greatest concentration of elements of the outermost 15 starburst are located generally on the outside of, but still within, the iris section, and generally on the outside of the concentration of elements of the outer starburst. The greatest concentration of elements of the outer starburst is located generally on the outside of the greatest concentration of elements of the inner starburst, and a first uneven border differentiates the outermost 20 starburst and the outer starburst, although the outermost starburst and the outer starburst potions will overlap. A second uneven border differentiates the outer starburst and the inner starburst, although the outer and inner starbursts overlap. Thus, a lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance is provided. 25 The steps used to deposit the intermittent pattern on the lens surface include using a first plate having depressions corresponding to the first portion or outermost starburst and filling the depressions with colorant of the first shade, preferably black. The next step is pressing a first flexible pad against the first plate and subsequently pressing the first flexible pad against the 30 surface of the lens (either side) thereby printing the first portion of the elements.

WO 01/50183 PCT/USO1/00067 -20 The next step involves using a second plate having depressions corresponding to the second portion or outer starburst and filling in the depressions with colorant of the second shade which is different from the first shade, preferably blue, green, gray or brown. The next step is pressing the 5 second flexible pad against a second plate and pressing the second flexible pad against the surface of the lens (either the same or the opposite surface) thereby printing the second portion of the elements. The final step involves using a third plate having depressions corresponding to the third portion or inner starburst and filling the depressions 10 with colorant of the third shade which is different from the second shade and is either the same or different from the first shade, preferably hazel. Pressing a third flexible pad against the third plate and pressing the third flexible pad against said surface of the lens (either side) thereby printing the third portion of the elements. 15 Although the steps listed above place an order to the printing of the portions on the lens, the order of printing is not important to the present invention and any other order of printing would be covered by the present invention. Further, the process described above may include the maximum and minimum distances, creating the uneven borders, previously listed in the 20 alternative embodiments. An alternative embodiment for printing the different layers on the iris section of the contact lens provides for ink-jet printing instead of pad printing of each layer. Ink-jet printing is accomplished without the need of pads or plates and can be administered at a higher resolution than pad printing, 25 thereby providing for greater detail of each colored layer and a more natural final pattern on the iris section of the contact lens. Using ink-jet printing also reduces the number of devices that make contact either with the contact lens or with other devices. For example, a silicon pad must make contact with a plate or cliche initially and then with the 30 contact lens itself. Contact between the parts tends to wear down the parts, which will then require replacements. During the ink-jet process, the micro- WO 01/50183 PCT/USO1/00067 -21 nozzles do not physically make contact with the contact lens, nor with any other device. The chance of the micro-nozzle wearing out is thereby reduced. Further, the ink-jet printer is electronically controlled such that changing from one color layer to a different color layer can be done easily, by computer 5 control. Thus, once a contact lens design is determined and separated into its multiple colored layers, each layer can be applied to the colored contact lens using an ink-jet process, thereby creating a colored contact lens capable of changing the apparent color of the wearer's iris. It can be seen that the present invention provides lenses capable of 10 changing the appearance of the wearer's iris, while allowing visualization of the fine structure thereof. Various changes may be made in the function and arrangement of parts: equivalent means may be substituted for those illustrated and described; and certain features may be used independently from others without departing from the spirit and scope of the invention as 15 defined in the following claims.

Claims

1. A colored contact lens comprising a non-opaque pupil section, an iris section surrounding said pupil section, and a colored, opaque intermittent pattern made up of a plurality of elements located over said entire iris section 5 that leaves a substantial portion within the interstices of the pattern non-opaque, said pattern covering an effective amount of the said iris section to change the apparent color of the iris, said pattern comprising: a plurality of portions, each of said portions being a different shade from each other portion, each of said portions overlapping each other portion at a plurality of 10 points, wherein at least one of said plurality of portions contains a design selected from the group consisting of uniform and non-uniform dots, islands of color, worms, starbursts, corkscrews, spokes, spikes, striations, radial stripes, zig-zags and streaks, thereby providing a lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very 15 natural appearance.

2. The colored contact lens in accordance with Claim 1 wherein the effective amount is between 10 and 30 % of the area of said iris section.

3. The colored contact lens in accordance with Claim 2 wherein the effective amount is approximately at least 20% of the area of said iris section. 20

4. The colored contact lens in accordance with Claim 3 wherein said plurality of portions comprises at least three different portions.

5. The colored contact lens in accordance with Claim 4, wherein said elements of the pattern comprise three shades, a first shade, a second shade and a third shade. 25

6. The colored contact lens in accordance with Claim 5 wherein said first shade is a color selected from the group consisting of gray, dark brown, dark blue and black, said second shade is a color selected from the group WO 01/50183 PCT/USO1/00067 -23 consisting of blue, green, gray, turquoise, hazel, light blue, violet, blue-violet, aqua, yellow or brown, and said third shade is a color selected from the group consisting of hazel, yellow, yellow-green, brown, yellow-brown, gold and orange. 5

7. The colored contact lens in accordance with Claim 5 wherein said first shade, said second shade, and said third shade are colors selected from the group consisting of blue, green, gray or brown, black, hazel, dark brown, dark blue, light blue, violet, blue-violet, aqua, turquoise, yellow, yellow-green, yellow-brown, gold and orange. 10

8. The colored contact lens in accordance with Claim 5 wherein said first shaded portion is a darkest shaded portion, said third shaded portion is a lightest shaded portion, and said second shaded portion is neither the darkest shaded portion nor lightest shaded portion, wherein said darkest portion has a greatest concentration of elements located generally outside said lightest 15 shaded portion, and outside said at least one portion which is neither the darkest shaded nor lightest shaded portion.

9. The colored contact lens in accordance with Claim 1 wherein the non-opaque interstices are uncolored.

10. A colored contact lens in accordance with Claim 1 wherein the 20 non-opaque interstices are translucently colored.

11. A colored contact lens in accordance with Claim 1 wherein the elements of the pattern are transparent.

12. A colored contact lens in accordance with Claim 1 wherein said colored contact is hydrophilic. WO 01/50183 PCT/USO1/00067 -24

13. A colored contact lens in accordance with Claim 1 wherein said portions comprise a substantially concentric pattern surrounding said pupil section.

14. A colored contact lens in accordance with Claim 13 wherein said 5 substantially concentric patterns have irregular borders.

15. A colored contact lens in accordance with Claim 13 wherein said substantially concentric patterns comprise projections which may extend to the periphery of the pupil section or the periphery of the iris section.

16. A colored contact lens comprising a non-opaque pupil section, an iris 10 section surrounding said pupil section, and a colored, opaque intermittent pattern made up of a plurality of elements located over said entire iris section that leaves a substantial portion within the interstices of the pattern non-opaque, said pattern covering an effective amount of the said iris section to change the apparent color of the iris, said pattern comprising: a plurality of 15 portions, each of said portions being a different shade from each other portion such that said pattern consists of a darkest shaded portion, a lightest shaded portion, and at least one portion which is neither the darkest shaded nor lightest shaded portion, each of said portions overlapping each other portion at a plurality of points, wherein said darkest portion has a greatest 20 concentration of elements located generally outside said lightest shaded portion, and outside said at least one portion which is neither the darkest shaded nor lightest shaded portion, thereby providing a lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance. 25

17. The colored contact lens in accordance with Claim 16 wherein the effective amount is between 10 and 30% of the area of said iris section.

18. The colored contact lens in accordance with Claim 17 wherein the effective amount is approximately at least 20% of the area of said iris section. WO 01/50183 PCT/USO1/00067 -25

19. The colored contact lens in accordance with Claim 18 wherein said plurality of portions comprises at least three different portions.

20. The colored contact lens in accordance with Claim 19 wherein said at least three different portions comprise different patterns each pattern being 5 made up of elements selected from the group consisting of uniform and non uniform dots, islands of color, worms, starbursts, corkscrews, spokes, spikes, striations, radial stripes, zig-zags and streaks.

21. The colored contact lens in accordance with Claim 20, wherein said elements of the pattern comprise three shades, a first shade, a second shade 10 and a third shade.

22. The colored contact lens in accordance with Claim 20 wherein said first shade is a color selected form the group consisting of gray, dark brown, dark blue and black, said second shade is a color selected from the group consisting of blue, green, gray, turquoise, hazel, light blue, violet, blue-violet, 15 aqua, yellow or brown, and said third shade is a color selected from the group consisting of hazel, yellow, yellow-green, brown, yellow-brown, gold and orange.

23. The colored contact lens in accordance with Claim 20 wherein said first shade, said second shade, and said third shade are colors selected from the 20 group consisting of blue, green, gray or brown, black, hazel, dark brown, dark blue, light blue, violet, blue-violet, aqua, turquoise, yellow, yellow-green, yellow-brown, gold and orange.

24. The colored contact lens in accordance with Claim 16 wherein the non-opaque interstices are uncolored.

25 25. The colored contact lens in accordance with Claim 16 wherein the non-opaque interstices are translucently colored. WO 01/50183 PCT/USO1/00067 -26

26. The colored contact lens in accordance with Claim 16 wherein the elements of the pattern are transparent.

27. The colored contact lens in accordance with Claim 16 wherein said colored contact is hydrophilic. 5

28. A colored contact lens in accordance with Claim 16 wherein said portions comprise a substantially concentric pattern surrounding said pupil section.

29. A colored contact lens in accordance with Claim 28 wherein said substantially concentric patterns have irregular borders. 10

30. A colored contact lens in accordance with Claim 28 wherein said substantially concentric patterns comprise projections which may extend to the periphery of the pupil section or the periphery of the iris section.

31. A colored contact lens comprising a non-opaque pupil section, an iris section surrounding said pupil section, and a colored, opaque intermittent 15 pattern made up of a plurality of elements located over said entire iris section that leaves a substantial portion within the interstices of the pattern non-opaque, said pattern covering an effective amount of the said iris section to change the apparent color of the iris, said pattern comprising: at least three portions, each of said at least three portions being a different shade from each 20 other portion, each of said portions overlapping each other portion at a plurality of points, wherein said overlapping portions commingle at a plurality of locations, said commingling of portions being indiscernible to the ordinary viewer, thereby providing a lens capable of changing the apparent color of the iris of a person wearing the lens and imparting a very natural appearance. 25

32. The colored contact lens in accordance with Claim 31 wherein the effective amount is between 10 and 30 % of the area of said iris section. WO 01/50183 PCT/USO1/00067 -27

33. The colored contact lens in accordance with Claim 32 wherein the effective amount is approximately at least 20% of the area of said iris section.

34. The colored contact lens in accordance with Claim 33 wherein said plurality of portions comprises at least three different portions. 5

35. The colored contact lens in accordance with Claim 34 wherein said at least three different portions comprise different patterns each pattern being made up of elements selected from the group consisting of uniform and non uniform dots, islands of color, worms, starbursts, corkscrews, spokes, spikes, striations, radial stripes, zig-zags and streaks. 10

36. The colored contact lens in accordance with Claim 35, wherein said elements of the pattern comprise three shades, a first shade, a second shade and a third shade.

37. The colored contact lens in accordance with Claim 36 wherein said first shade is a color selected form the group consisting of gray, dark brown, dark 15 blue and black, said second shade is a color selected from the group consisting of blue, green, gray, turquoise, hazel, light blue, violet, blue-violet, aqua, yellow or brown, and said third shade is a color selected from the group consisting of hazel, yellow, yellow-green, brown, yellow-brown, gold and orange. 20

38. The colored contact lens in accordance with Claim 36 wherein said first shade, said second shade, and said third shade are colors selected from the group consisting of blue, green, gray or brown, black, hazel, dark brown, dark blue, light blue, violet, blue-violet, aqua, turquoise, yellow, yellow-green, yellow-brown, gold and orange. 25

39. The colored contact lens in accordance with Claim 36 wherein said first shaded portion is a darkest shaded portion, said third shaded portion is a lightest shaded portion, and said second shaded portion is neither the darkest WO 01/50183 PCT/USO1/00067 -28 shaded portion nor lightest shaded portion, wherein said darkest portion has a greatest concentration of elements located generally outside said lightest shaded portion, and outside said at least one portion which is neither the darkest shaded nor lightest shaded portion. 5

40. The colored contact lens in accordance with Claim 31 wherein the non-opaque interstices are uncolored.

41. The colored contact lens in accordance with Claim 31 wherein the non-opaque interstices are translucently colored.

42. The colored contact lens in accordance with Claim 31 wherein the 10 elements of the pattern are transparent.

43. The colored contact lens in accordance with Claim 31 wherein said colored contact is hydrophilic.

44. A colored contact lens in accordance with Claim 31 wherein said portions comprise a substantially concentric pattern surrounding said pupil 15 section.

45. A colored contact lens in accordance with Claim 44 wherein said substantially concentric patterns have irregular borders.

46. A colored contact lens in accordance with Claim 44 wherein said substantially concentric patterns comprise projections which may extend to 20 the periphery of the pupil section or the periphery of the iris section.

47. A colored contact lens comprising a non-opaque pupil section, an iris section surrounding said pupil section, and a colored, intermittent pattern made up of a plurality of elements located over said entire iris section that leaves a substantial portion of the pattern non-opaque, said pattern covering 25 an effective amount of the said iris section to change the apparent color of the WO 01/50183 PCT/USO1/00067 -29 iris, said pattern comprising: at least three portions, each of said at least three portions being a different shade from each other portion, each of said portions overlap each other portion at a plurality of points, wherein said overlapping portions blend together to produce the appearance of unique textures and 5 colors, said blending portions being indiscernible to the ordinary viewer, thereby providing a lens capable of changing the apparent color of the iris of a person wearing the lens while imparting a very natural appearance.

48. The colored contact lens in accordance with Claim 47 wherein the effective amount is between 10 and 30 % of the area of said iris section. 10

49. The colored contact lens in accordance with Claim 48 wherein the effective amount is approximately at least 20% of the area of said iris section.

50. The colored contact lens in accordance with Claim 49 wherein said plurality of portions comprises at least three different portions.

51. The colored contact lens in accordance with Claim 50 wherein said at 15 least three different portions comprise different patterns each pattern being made up of elements selected from the group consisting of uniform and non uniform dots, islands of color, worms, starbursts, corkscrews, spokes, spikes, striations, radial stripes, zig-zags and streaks.

52. The colored contact lens in accordance with Claim 51, wherein said 20 elements of the pattern comprise three shades, a first shade, a second shade and a third shade.

53. The colored contact lens in accordance with Claim 52 wherein said first shade is a color selected form the group consisting of gray, dark brown, dark blue and black, said second shade is a color selected from the group 25 consisting of blue, green, gray, turquoise, hazel, light blue, violet, blue-violet, aqua, yellow or brown, and said third shade is a color selected from the group WO 01/50183 PCT/USO1/00067 -30 consisting of hazel, yellow, yellow-green, brown, yellow-brown, gold and orange.

54. The colored contact lens in accordance with Claim 52 wherein said first shade, said second shade, and said third shade are colors selected from the 5 group consisting of blue, green, gray or brown, black, hazel, dark brown, dark blue, light blue, violet, blue-violet, aqua, turquoise, yellow, yellow-green,, yellow-brown, gold and orange.

55. The colored contact lens in accordance with Claim 52 wherein said first shaded portion is a darkest shaded portion, said third shaded portion is a 10 lightest shaded portion, and said second shaded portion is neither the darkest shaded portion nor lightest shaded portion, wherein said darkest portion has a greatest concentration of elements located generally outside said lightest shaded portion, and outside said at least one portion which is neither the darkest shaded nor lightest shaded portion. 15

56. The colored contact lens in accordance with Claim 47 wherein the non-opaque interstices are uncolored.

57. The colored contact lens in accordance with Claim 47 wherein the non-opaque interstices are translucently colored.

58. The colored contact lens in accordance with Claim 47 wherein the 20 elements of the pattern are transparent.

59. The colored contact lens in accordance with Claim 47 wherein said colored contact is hydrophilic.

60. A colored contact lens in accordance with Claim 47 wherein said portions comprise a substantially concentric pattern surrounding said pupil 25 section. WO 01/50183 PCT/USO1/00067 -31

61. A colored contact lens in accordance with Claim 60 wherein said substantially concentric patterns have irregular borders.

62. A colored contact lens in accordance with Claim 60 wherein said substantially concentric patterns comprise projections which may extend to 5 the periphery of the pupil section or the periphery of the iris section.

63. A colored contact lens comprising a non-opaque pupil section, an iris section surrounding said pupil section, and a colored, intermittent pattern made up of a plurality of elements located over said entire iris section that leaves a substantial portion of the pattern non-opaque, said pattern covering 10 an effective amount of the said iris section to change the apparent color of the iris, said pattern comprising: a plurality of portions, each of said plurality of portions being either a concentric portion or a radial portion, wherein said portions blend together to produce the appearance of unique textures and colors, thereby providing a lens capable of changing the apparent color of the 15 iris of a person wearing the lens while imparting a very natural appearance.

64. The colored contact lens in accordance with Claim 63 wherein the effective amount is between 10 and 30 % of the area of said iris section.

65. The colored contact lens in accordance with Claim 64 wherein the effective amount is approximately at least 20% of the area of said iris section. 20

66. The colored contact lens in accordance with Claim 65 wherein said plurality of portions either overlap completely or overlap partially.

67. The colored contact lens in accordance with Claim 66 wherein each of said radial portions is connected to each other.

68. The colored contact lens in accordance with Claim 66 wherein each of 25 said radial portions is separate from each other. WO 01/50183 PCT/USO1/00067 -32

69. The colored contact lens in accordance with Claim 66 wherein each of said radial portions is irregularly shaped.

70. The colored contact lens in accordance with Claim 66 wherein each of said portions are colors selected from the group consisting of blue, green, 5 gray or brown, black, hazel, dark brown, dark blue, light blue, violet, blue violet, aqua, turquoise, yellow, yellow-green, yellow-brown, gold and orange.

71. The colored contact lens in accordance with Claim 66 wherein said first shaded portion is a darkest shaded portion, said third shaded portion is a lightest shaded portion, and said second shaded portion is neither the darkest 10 shaded portion nor lightest shaded portion, wherein said darkest portion has a greatest concentration of elements located generally outside said lightest shaded portion, and outside said at least one portion which is neither the darkest shaded nor lightest shaded portion.

72. The colored contact lens in accordance with Claim 63 wherein the 15 non-opaque interstices are uncolored.

73. The colored contact lens in accordance with Claim 63 wherein the non-opaque interstices are translucently colored.

74. The colored contact lens in accordance with Claim 63 wherein the elements of the pattern are transparent. 20

75. The colored contact lens in accordance with Claim 63 wherein said colored contact is hydrophilic.

76. A colored contact lens in accordance with Claim 63 wherein said portions comprise a substantially concentric pattern surrounding said pupil section. WO 01/50183 PCT/USO1/00067 -33

77. A colored contact lens in accordance with Claim 76 wherein said substantially concentric patterns have irregular borders.

78. A colored contact lens in accordance with Claim 76 wherein said substantially concentric patterns comprise projections which may extend to 5 the periphery of the pupil section or the periphery of the iris section.

79. A method for manufacturing a colored contact lens having a non-opaque pupil section, an iris section surrounding said pupil section, and a colored, intermittent pattern made up of a plurality of elements located over said entire iris section that leaves a substantial portion of the pattern 10 non-opaque, said pattern covering an effective amount of said iris section to change the apparent color of the iris, comprising the steps of: a) providing a transparent contact lens; b) applying a plurality of portions of colorant to the surface of the contact lens, such that said colorant covers an effective amount of said iris 15 section, each of said portions overlapping each other portion at a plurality of points, wherein said overlapping portions blend together to produce the appearance of unique textures and colors, thereby providing a lens capable of changing the apparent color of the iris of a person wearing the lens while imparting a very natural appearance. 20

80. The colored contact lens in accordance with Claim 79 wherein the effective amount is between 10 and 30 % of the area of said iris section.

81. The colored contact lens in accordance with Claim 80 wherein the effective amount is approximately at least 20% of the area of said iris section.

82. The colored contact lens in accordance with Claim 81 wherein said 25 plurality of portions comprises at least three different portions.

83. The colored contact lens in accordance with Claim 82 wherein said at least three different portions comprise different patterns each pattern being WO 01/50183 PCT/USO1/00067 -34 made up of elements selected from the group consisting of uniform and non uniform dots, islands of color, worms, starbursts, corkscrews, spokes, spikes, striations, radial stripes, zig-zags and streaks.

84. The colored contact lens in accordance with Claim 83, wherein said 5 plurality of portions of colorant comprise three shades, a first shade, a second shade and a third shade.

85. The colored contact lens in accordance with Claim 84 wherein said first shade is a color selected form the group consisting of gray, dark brown, dark blue and black, said second shade is a color selected from the group 10 consisting of blue, green, gray, turquoise, hazel, light blue, violet, blue-violet, aqua, yellow or brown, and said third shade is a color selected from the group consisting of hazel, yellow, yellow-green, brown, yellow-brown, gold and orange.

86. The colored contact lens in accordance with Claim 84 wherein said first 15 shade, said second shade, and said third shade are colors selected from the group consisting of blue, green, gray or brown, black, hazel, dark brown, dark blue, light blue, violet, blue-violet, aqua, turquoise, yellow, yellow-green, yellow-brown, gold and orange.

87. The colored contact lens in accordance with Claim 84 wherein said first 20 shade is a darkest shaded portion, said third shade is a lightest shaded portion, and said second shad is neither the darkest shade nor the lightest shade, wherein said darkest portion has a greatest concentration of elements located generally outside said lightest shaded portion, and outside said at least one portion which is neither the darkest shaded nor lightest shaded 25 portion.

88. The colored contact lens in accordance with Claim 79 wherein the elements of the pattern are transparent. WO 01/50183 PCT/USO1/00067 -35

89. The colored contact lens in accordance with Claim 79 wherein said colored contact is hydrophilic.

90. A colored contact lens in accordance with Claim 79 wherein said portions comprise a substantially concentric pattern surrounding said pupil 5 section.

91. A colored contact lens in accordance with Claim 90 wherein said substantially concentric patterns have irregular borders.

92. A colored contact lens in accordance with Claim 90 wherein said substantially concentric patterns comprise projections which may extend to 10 the periphery of the pupil section or the periphery of the iris section.

93. The method for manufacturing a colored contact lens in accordance with Claim 79 wherein said applying a plurality of portions of colorant comprises using an ink-jet printer to apply each of said plurality of portions of colorant. 15