PATENT APPLICATION

Attorney Docket No. P07137US (99270.1P) PCT Attorney Docket No. P07137WO (99270. IPWO) TITLE OF THE INVENTION MEDICATION DISPENSING PACKAGE AND METHOD

INVENTOR: Steve H. KANZER, a US citizen, of Ann Arbor, MI ASSIGNEE:

PIPEX PHARMACEUTICALS, INC. (a Delaware, US, corporation), 3930 Varsity Drive, Ann Arbor, Michigan 48108, US. CROSS-REFERENCE TO RELATED APPLICATIONS

Priority of US Provisional Patent Application Serial No. 60/948,827, filed 10 July 2007, incorporated herein by reference, is hereby claimed.

Priority of US Provisional Patent Application No. 60/987,024, filed 9 November 2007, incorporated herein by reference, is hereby claimed. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable REFERENCE TO A "MICROFICHE APPENDIX"

Not applicable BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medication dispensing packages that contain and dispense pills, tablets or like medications to a patient diagnosed with age-related macular degeneration (AMD), wherein the packaging generates frequent self-testing by the patient by locating a self-testing chart or grid on a package surface and as part of a specially configured pill dispensing device.

2. General Background of the Invention

Age-related macular degeneration is the leading cause of blindness of people over the age of 50 and affects an estimated 30% of people over the age of 75; 90% of persons with AMD have the early form known as dry AMD while the remaining 10% of AMD sufferers have already converted to the later highly destructive form of AMD known as wet or exudative AMD. Since 1988 when David A. Newsome first demonstrated the

utility of daily oral zinc therapy for dry AMD, treatment of dry AMD seeks to achieve two separate goals: (1) daily treatment with ocular vitamins to prevent disease progression and (2) early detection of retinal events indicative of the potential conversion from the dry form to the wet form. Aggressive new therapies such as intraocular injected anti-VEGF inhibitors (anti-vascular endothelial growth factor inhibitors) are useful for stopping the progression of wet AMD but patient outcomes very much depend upon how early the wet AMD is detected and treated, hence the importance of early detection.

The following possibly relevant prior art is cited by the inventor to further demonstrate the novelty and utility of the herein described invention over the prior art: US Patent No. 6,874,652 describes a dispenser for tablets contained in a blister pack but does neither describe an eye self-test nor a mounted position.

International publication number WO 2004/000703 Al describes a dispenser for dispensing solid objects but neither describes an eye-self-test nor a mounted position. US Patent No. 5,133,478 describes a mountable pill dispenser for organizing a patient's calendar of different medications especially useful as a low vision aid but does not describe an eye-self-test nor does it specifically describe dispensing medicaments useful for AMD.

US Patent No. 6,494,579 describes a mountable eye-self-test device that informs the user at a specific interval period that it is time to perform an eye self-test but neither describes, incorporates nor facilitates medication compliance or dispensing. Such device relies instead on a visual or audible means to remind the patient to take the eye self-test which like all other prior relies exclusively on patient eye self- test compliance completely separate from the practice of daily medication dispensing and medication compliance.

U.S. Patent Publication No. US 2004/0091454 claims a method of treating AMD by administration of a "selective cytokine inhibitory drug" . Such patent application also describes at paragraph [0028], "a kit comprising: a pharmaceutical composition comprising a selective cytokine inhibitory drug, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof. The invention further encompasses kits comprising single unit dosage forms. Kits encompassed by this invention can further comprise additional active agents. A specific kit comprises an Amsler grid useful for detecting or diagnosing MD." At paragraph [0283] such application describes, "Kits of the invention can further comprise devices that are used

to administer the active agents. Examples of such devices include, but are not limited to, syringes, drip bags, patches, and inhalers. A kit of the invention can further comprise an Amsler grid useful for detecting or diagnosing MD." Such kit is distinguishable from the present invention since it does not anticipate the incorporation of a pill dispenser with an eye self-test so as to improve compliance by combining the two activities. Such kit merely describes inclusion of an Amsler grid in the kit but does not provide for a dispensing or mounting means. Such kit is akin to the inclusion of an Amsler grid in or together with a package insert in a carton containing a typical bottle of Bausch & Lomb Preservision or Ocuvite or Alcon iCaps. Once the Amsler grid is separated from the dispensing bottle, the daily activity of pill dispensing is completely separated from the daily routine of eye self-testing as is the case with most Amsler grids currently supplied by ophthalmologists to patients.

Personal digital assistants ("PDAs") are handheld computers, but have become much more versatile over the years. PDAs are also known as pocket computers or palmtop computers. PDAs have many uses: calculation, use as a clock and calendar, accessing the Internet, sending and receiving E-mails, video recording, typewriting and word processing, use as an address book, making and writing on spreadsheets, scanning bar codes, use as a radio or stereo, playing computer games, recording survey responses, and Global Positioning System (GPS). Newer PDAs also have both color screens and audio capabilities, enabling them to be used as mobile phones (smartphones), web browsers, or portable media players. Many PDAs can access the Internet, intranets or extranets via Wi-Fi, or Wireless Wide-Area Networks (WWANs). Many PDAs employ touch screen technology.

Currently, a typical personal digital assistant or "PDA" has a touch screen for entering data, a memory card slot for data storage and at least one of the following for connectivity: IrDA, Bluetooth and/or WiFi. However, many PDAs (typically those used primarily as telephones) may not have a touch screen, using softkeys, a directional pad and either the numeric keypad or a thumb keyboard for input. BRIEF SUMMARY OF THE INVENTION The apparatus of the present invention provides an apparatus for containing and dispensing medications (e.g. pills, tablets, powders) to a patient that has been diagnosed with a form of macular degeneration. The apparatus includes a specially configured

package containing the medication to be dispensed and a diagnostic chart on the package that enables the patient to conduct an eye self-test each time the patient dispenses medication from the package.

The present invention offers dry AMD patients much greater convenience and improved patient compliance by co-reinforcing the daily routine of pill dispensing together with a daily routine of self-testing for early detection of retinal events. The present invention accomplishes this by incorporating both routines into a device thereby permitting both tasks to be accomplished by patients at relatively the same time. In this way the routine of eye self-testing reinforces compliance with daily pill regimen and the daily routine of pill dispensing reinforces eye self-testing. The present invention provides prescribing physicians much greater confidence that a patient will comply with the physician's regular eye self-testing instructions between regular exams.

An embodiment of the present invention comprises a pill (or other oral drug delivery method, or means such as for example a chewable or effervescent tablet, capsule, tablet or powder) dispenser or container having or incorporating a flat surface of sufficient area to display in for example printed and/or electronic form an eye self-test for early detection of retinal events, such as an Amsler grid, "blind spot" Amsler grid, or peripheral hyperacuity self-test. In a preferred embodiment the invention can incorporate a written or electronic recording means such as a touch screen to record the results of the patient's self-test such as by pen on one or more Amsler grids. In such a case, the present invention can optionally and preferably include a test of the patient's eyesight in which the patient touches the touch screen with a finger or a device and the results of the test are preferably recorded for review by the patient or his doctor.

In a preferred embodiment, the present invention can optionally be mounted on a refrigerator, wall or stand to further aid compliance.

In one embodiment, the present invention can include a touch screen device that patient can touch to test his eyesight.

In one embodiment, the present invention can include a computer monitor or computer screen instead of a touch screen, with optional voice activation/voice recognition (such as a wireless microphone, such as one that is Bluetooth enabled and that would include voice recognition technology). Such voice activation/voice recognition would enable identification of user responses to letters and/or symbols

presented on the screen to measure and/or track a patient's visual acuity at various lighting and visual conditions.

In a further preferred embodiment the invention can contain or comprise a blister card supply of pills whereby an eye self-test is imprinted on a non-breakable surface affixed to such blister card or container housing such blister card. (See, for example, Figures 1, 2 and 3).

In a further embodiment the invention comprises a pill dispenser containing a magazine of bulk pills, loose bulk pills or a blister card of pills (or tablets or powder) that permits the dispensing of a single pill or daily supply of pills upon mechanical and/or electronic activation by the patient whereby an eye self-test is imprinted or incorporated on a flat surface.

In a further embodiment, the dispenser can incorporate emergency contact information for the patient to contact if the patient suspects that a retinal event may have occurred. In a further embodiment the written or electronic recording means can be saved and utilized by the patient and/or doctor to track the patient's disease progression.

In a preferred embodiment the invention can comprise two separate eye self- tests, one for the left eye and one for the right eye. Eye self-tests may comprise an Amsler grid in which the grid appears light against a dark background or dark against a light background.

The present invention can include a writing instrument or touch screen wand as a recording means.

The present invention can incorporate a magnetic or adhesive strip or hanger means for attaching to a door or wall. The present invention can be disposable in its entirety or comprise disposable components such as a disposable magazine or blister card of pills that integrates with the eye self-test device.

A preferred embodiment of the present invention comprises a flat surface containing one or more Amsler grids that comprises a housing containing one or more blister cards containing pills. The patient gains access to the pill by either sliding the blister card out (see Figures 1-2) or activating a hinge which exposes the blister card or depresses the Amsler grid or presses on the top PVC layer of the blister card thereby

pressing and breaking the underlying foil layer and further pressing the pill through a hard grate that allows the pill to be released from an empty free cavity, allowing it free fall by gravity into a collection tray at the bottom of the dispenser (see Figures 3-5).

In a preferred embodiment, the blister card can remain exposed as under a printed calendar that is adjacent to an eye self- test.

In a preferred embodiment, a blister card containing pills can be organized in columns of seven corresponding to days of the week and rows corresponding to weeks of the month and or times per day, for example.

Alternatively, the blister card can arrange the pills in a circular blister wheel layout allowing a mechanism within or behind the eye self-test to press out and dispense a pill while advancing the revolving blister wheel to the next pill to be punched out as described more specifically in US Patent No. 6,874,652 (see Figure 6).

In a preferred embodiment the present invention comprises a mountable pill dispenser that dispenses pills containing any one or more of the ingredients selected from the group consisting of zinc monocysteine, zinc, lutein, vitamin A, vitamin C, vitamin E, and the Age-Related Eye Disease Study 1 (AREDSl) formulation.

In a preferred embodiment the present invention comprises a blister card pill dispenser that is mountable to a refrigerator or wall by magnetic, adhesive, nail, screw or hook whereby upon pressing the pill is pressed through a grid into a free cavity behind such grid and is permitted to drop into a collection tray.

In a preferred embodiment the present invention comprises a bulk fill or cartridge pill dispenser that can have a desiccant and/or moisture barrier means for maintaining product stability features (as described international publication number WO 2004/000703 Al) and that is mountable to a refrigerator or wall by magnetic, adhesive, nail, screw or hook whereby upon activation the pill or pills are dispensed by gravity into a collection tray.

In a preferred embodiment, the bulk fill pill containers or pill cartridges can be filled and prepared by a pharmacist and are placed or affixed into the device for individual release by an actuator operated by the patient or automatically by electronically programmable means via automatic electronic actuation or electronically visible means such as by LED indicator visible to the patient. Such device as described may be compatible with standard mouth and thread sizes of plastic pharmacy bottles preferably

inverted for dispensing or special disposable cartridges supplied to the pharmacist for filling.

The eye self-tests can be in the form of tearable or roll sheets on which test results may be recorded and saved either separately or within the device. The pill dispenser can incorporate a child-proof mechanism such as an optional lock other activation mechanism such as a simultaneous dual activation means.

The present invention can contain a collecting tray at its bottom for collecting dispensed pills from a vertically mounted position. In a preferred embodiment the present invention may dispense more than one pill corresponding to the recommended number of daily doses. Thus, the patient can perform a single eye test in the morning thereby actuating the device to release the multiple pills allowing the patient to take one pill immediately with the remaining dispensed pills serving as a convenient reminder to take them later in the day.

In a preferred embodiment, the patient can press a spring-loaded push button that is located in the center, within, under, over, behind, or comprising an Amsler grid whereby such push button mechanically or electronically dispenses one or more pills (see Figure 3).

The invention can also preferably comprise a mountable calendar incorporating one or more eye-self-test or tests. In a preferred embodiment, the present invention may provide a means of reminding the patient of the patient's next scheduled appointment with the treating physician. The present invention may also be printed or labeled with contact and other information relating of the treating physician.

In a preferred embodiment the present invention can also comprise a calendar style pill dispenser incorporating an eye self-test in which the dispenser comprises a plurality of containers arranged in a matrix that in addition to AMD medications may also be filled with other medications of the patient corresponding to days and/or times of the week as a low- vision aid to assist the AMD patient with the proper dispensing of such AMD patient's other daily medications.

In a preferred embodiment, the invention can contain one or more active ingredients selected from the group of, zinc monocysteine, zinc, lutein, vitamin A, vitamin C, vitamin E, and the AREDSl formulation.

Preferably, the active ingredients will delay, stop, or even more preferably reverse

progression of the disease.

All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:

Figure 1 is a front view of the preferred embodiment of the apparatus of the present invention;

Figure 2 is a front view of the preferred embodiment of the apparatus of the present invention showing the blister card sliding out of the package;

Figure 3 is a perspective view of the preferred embodiment of the apparatus of the present invention; Figure 4 is a sectional view taken along lines 4-4 of figure 2;

Figure 5 is a sectional view taken along lines 5-5 of figure 3;

Figure 6 is a perspective view of an alternate embodiment of the apparatus of the present invention;

Figure 7 is a perspective view of the preferred embodiment of the apparatus of the present invention showing attachment to an appliance, cabinet, vertical surface;

Figure 8 is a fragmentary view of the preferred embodiment of the apparatus of the present invention;

Figure 9 is a rear perspective view of the preferred embodiment of the apparatus of the present invention; Figure 10 is a rear perspective view of the preferred embodiment of the apparatus of the present invention; and

Figures 11-30 show another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

Figures 1-2 and 4 show a preferred embodiment of the apparatus of the present invention designated generally by the numeral 10. Medicine dispensing apparatus 10 provides a package or container 11 that can be comprised of a plurality of panels, the panels surrounding an interior or void space that holds a pill containing insert (e.g. blister

card) 20.

Package/container 11 can thus include a pair of side panels 12, 13 , a pair of end panels 14, 15, abottom panel 16 and a top panel 17. Package or container 11 can include one or more closure flaps 18 that can be opened for exposing and retrieving pill containing insert 20. Closure flap 18 can be positioned at panel 14 or 15 and can be attached to insert 20 (see figures 2 and 4).

A tab 29 on flap 18 can be used to remove insert 20 from the interior of package or container 11. Top panel 17 carries an eye self-test chart 19, such as a grid, that enables a patient to conduct an eye self-test. At the same time that the patient conducts the self test, the patient dispenses his or her medicine which can be in the form of a pill 24.

Pill containing insert 20 thus contains a plurality of pills/medicine 24 to be dispensed. As shown in figures 2, 4 and 8 insert 20 includes a plurality of pill containing void spaces 25 , each carrying pill 24 or other medicine or prescription in any known form such as for example, a single or multiple dosages of medicine as prescribed by the patient's physician.

Pill containing insert 20 can include a layer 22 (e.g. PVC or other plastic) laminated to foil layer 21 (see, for example, figure 8). Windows or openings 23 in the layer 22 are covered with foil layer 21. Additionally, each pill 24 is covered with a clear layer 26 such as for example, a clear plastic layer, enabling the patient to view pill 24 that is to be dispensed. Pill 24 to be dispensed is thus positioned in void space 25 generally in between foil layer 21 and clear layer 26.

The bottom panel 16 of package/container 11 can be fitted with a hanger for mounting the package or container 11 on a selected panel or surface 57 such as a wall or appliance 55 (for example, refrigerator) or any other generally inclined or vertical surface. Such a hanger can for example be in the form of magnetic strip 27 (figure 9) or adhesive strip 28 (figure 10), which can be a peel-apart adhesive such as a foam adhesive layer that is covered with a disposable release liner. Such a hanger 27 or 28 can be used with either the embodiment of figures 1-5 or the embodiment of figure 6.

In figures 3 and 5, another preferred embodiment of the apparatus is shown, designated by the numeral 30. The medicine dispensing apparatus 30 of figures 3 and 5 can also provide a package or container 31. In figures 3 and 5, the package/container is fitted with pivotally mounted panel 32. Panel 32 can be attached to package/container

31 using spring hinge 33. Package/container 31 has frontal portion 34 that can include layer 35 (for example, PVC, plastic), blister foil layer 36, and hard plastic grate layer 37. A cavity 38 is provided in between hard plastic grate 37 and a rear panel 42 of package/container 31. A pill receptive trough 40 is provided as a part of package/container 31, generally opposite spring hinge 33 as shown.

A release lock 39 or other closure can be provided as part of pivo tally mounted panel 32 for closing panel 32 upon package/container 31. Release lock 39 can be a push or pull type release lock that enables a user to free the panel 32 from its connection to package/container 31 by pushing on release lock 39. When release lock 39 is pushed (or pulled), panel 32 moves in the direction of arrow 44 to a position that forms an acute or right angle or obtuse angle with package/container rear panel 42. A patient is reminded to conduct an eye self-test each time that the patient dispenses a pill or other medicine 24 from package/container 31.

In order to dispense a pill or other medicine 24 from package/container 31, a patient pushes the release lock 39 so that panel 32 pivots away from package/container 31 in the direction of arrow 44, being moved by spring hinge 33. The patient then pushes on pill 24 wherein pill 24 ruptures blister foil 36 and enters cavity 38 that is behind hard plastic grate 37. The hard plastic grate 37 is provided with opening 58 behind each of the pills 24, that opening 58 being covered by the blister foil 36. When the patient pushes pill 24 toward rear panel 42, this application of force ruptures foil 36 immediately behind pill 24. Pill 24 enters cavity 38 and falls into pill receptive trough 40, as shown by arrow 53. Pill receptive trough 40 can be formed by a projection 41 that can be generally triangularly shaped in cross section as shown in figures 3 and 5. As the user retrieves pill 24, the user then closes panel 32 by pushing it, overcoming the spring hinge 33 until release lock 39 locks with tab 56.

Panel 32 carries an eye self-test chart 43 such as a grid that enables the patient to conduct an eye self-test that relates to the diagnosis of macular degeneration and/or the progression of macular degeneration or age related macular degeneration (AMD). By placing the eye self-test chart 43 on the front of pivo tally mounted panel 32, the patient is reminded to conduct a self-test each time that the patient dispenses pill 24 from package/container 31.

The chart 43 can be a paper chart to be manually marked by the patient. The chart

43 can include a touch screen device that a patient can touch to test his eyesight. The chart 43 can be a computer monitor or computer screen instead of a touch screen, with optional voice activation/voice recognition (such as a wireless microphone, such as one that is Bluetooth enabled and that would include voice recognition technology). Such voice activation/voice recognition would enable identification of user responses to letters and/or symbols presented on the screen to measure and/or track a patient's visual acuity at various lighting and visual conditions.

Figure 6 shows another embodiment of the apparatus of the present invention, designated generally by the numeral 45. Medicine dispensing apparatus 45 provides a package/container 46 having an interior or void space 47. A blister card dispensing wheel 48 is contained within interior 47 of package/container 46. A front panel/actuator push button 49 is provided as part of package/container 46. The front panel/actuator push button 49 dispenses a single pill 24 when the front panel/actuator push button 49 is depressed. The front panel/actuator push button 49 provides an eye self-test chart 50 such as a grid that enables a patient to conduct an eye self- test for diagnosing macular degeneration or progression of macular degeneration or age related macular degeneration

(AMD).

The package/container 46 provides an opening 51 through which pill 24 passes when front panel/actuator push button 49 is depressed. Arrow 54 schematically illustrates the path of pill 24 that is dispensed from dispensing wheel 48 through opening

51 when front panel/actuator push button 49 is depressed. Pill 24 falls into collection tray

52.

Figures 7, 9, 10 schematically illustrate the attachment of package/container 11,

31, 46 to an appliance 55 such as a refrigerator, wherein a magnetic strip 27 or an adhesive strip 28 can be employed to secure the package/container 11, 31, 46 to the appliance 55.

An ocular kinetic offset acuity test is an interactive ocular is incorporated herein.

The test can be utilized by persons having access to a computer with a mouse tracking device. Alternatively, and in a preferred embodiment, the test is incorporated in a touch screen with a pointer which allows a patient to make a choice on the screen. In a more preferred embodiment, the test is incorporated in a pill dispensing device, which pills are useful for management of disease.

Further, the device can record results of each of the patient's test and thereby potentially monitor improvement or deterioration of the patient's macular diseases

Many such examples of such eye tests are disclosed in the literature. E.g. Okay test invented by Dr. William Sponsol, MD and also the peripheral vision testing incorporated into the flash focus computer game available on a Nintendo DS. In addition, a device specific for monitoring a patient's progress is also available as a machine known as the Foresee PHP marketed by NotalVision Inc. Some embodiments of the present invention overcome the limitations of the prior art in that they allow patients and doctors to conduct a visual field test or visual acuity test on machines that do not require a touch screen nor a dedicated device for the purpose of conducting such testing. The game does not require voice recognition capabilities as many computers do not have a microphone.

The visual eye test also does not require a significant amount of training and oversight by a technician to oversee and familiarize a patient with the test. Another embodiment of the present invention, Combined Pill Dispenser and

Personal Digital Assistant (Pill-PDA), is shown in Figs. 11-30.

Fig. 11 depicts the screen image 70 of the game prior to start, with a cursor 71 shown in the center of the screen 70 and multiple blocks or boxes 72 around the border of the screen 70. Fig. 12 depicts a randomly generated arrow 73 that may appear anywhere on the screen 70 within the borders of the outlined boxes 72 while the arrow 73 also randomly points directly to one of surrounding empty boxes 72 around the border of the area. The arrow 73 is flashed and appears briefly (for example one second or less) and can be adjusted for size of arrowhead, length, width, straight, curved, black, white on black, flashed, faded in, greyscaled, contrasted by darkness or by color or may rather be an object such as box similar to one around the border of the game as depicted as in Figs. 27 and 28.

Fig. 13 shows the game after the arrow 73 has disappeared from the screen.

Fig. 14 depicts the direction of the mouse cursor 71 changing in response to the user's drag-to direction. Change of direction of the mouse cursor 71 by mouse roll direction allows for near immediate measurement of intended patient response to visual stimulus further separating response time and direction between intended action and

actual eye hand coordinated action and is easy to use.

Fig. 15 depicts the movement of the mouse cursor 71 toward the direction of the box 72 selected by the user as being the box to which the user believes the briefly flashed arrow had pointed to. Fig. 16 represents the positive feedback 75 to the user and aids compliance through a point system to the user to achieve the highest score thereby engaging the user thus improving patient compliance and challenging the user to obtain higher scores. The scoring system, although having minor negative values for misses, is intended to score the user and reward the user with higher points for recognizing and discriminating for more difficult and challenging arrow placement by selecting the correct box and being awarded higher points. Sounds can be played to encourage the patient when they do well and an avatar can guide and instruct the patient on how to use the device, including left and right eye. A running score tally in the display of the user's score 74 since beginning the game is displayed for the user. Used in an eye care specialist's office, the exam can provide potential useful information for the specialist regarding any changes in the patient's macula and vision. It aids eye care specialists by freeing them up by allowing a computer generated talking avatar to guide them through the process. The specialist can return after the patient has completed the test and evaluate the results graphically as described later on. Fig. 17 represents the automatic return of the cursor 71 to the center of the field

70 so that the user's fixation remains in the center of the test prior to the instance of each test.

Fig. 18 represents the alternative scenario to Fig. 16 in which the user has not selected the correct box and a minor subtraction 76 from the patient's score 74 occurs as a result. A patient's score 74 can never be less than zero at any time. Depending on the nature and degree of the patient's disease, the scoring can be adjusted to award higher points for example to accommodate for patients that have various retinal defects. Known or observed retinal defects can be tested more rigorously as opposed to random placement depending upon program selected to run. Fig. 19 shows the user's final score 74 and also depicts the areas and potential extent and type of the user's macular defects based upon the average percentage of correct and incorrect selections in the visual field grid 77, with circles 78, 79, 80.

Fig. 20 demonstrates that over a period of time and using the test by saving the results of each test over a period of time the patient's visual field defects can be animated to easily and conveniently demonstrate the patient's potential disease progression or improvement. Fig. 20 shows circles 81, 82, 83. Fig. 21 demonstrates that a stylus 90 or finger (not shown) can be used in lieu of a mouse input. In addition, to these inputs, a joystick, thumbpad, mouse clicking, keyboard and voice recognition software such as integration of Dragon Naturally Speaking can be used to eliminate all necessity for eye hand coordination by identification of letter objects, tumbling E's or children's objects, for example. In these latter cases, a touch screen need not be used.

Fig.22 demonstrates photorecovery time measurement 91 in which a dark screen area 92 is displayed for a sufficient amount of time for a patient's iris to adjust to the dark light.

Fig. 23 demonstrates the bright white screen that is displayed to measure photorecovery time following the dark screen 92 of Fig. 22. The box 72 which may be placed elsewhere (such as in other figures) gradually fades in increasing contrast (as an arrow that points to a box in the other figures) and the device measures the time it takes the patient to correctly see such box and identify the box (as in the other figures the device measures the time it takes the patient to correctly see arrow 73 and identify the box 72 to which the arrow is directed).

Fig. 24 demonstrates the correct selection with a stylus 90 or mouse as described in Fig. 23.

Fig 25 demonstrates a fide test for contrast sensitivity, with shading 93 in a box 72. Fig.26 demonstrates correct selection and measurement 84 of contrast sensitivity.

Fig. 27 demonstrates a modified Ishihara test for color by utilizing a green arrow 94 against a red background 95 to create an arrow 94 directed at a box 72. The same test could be conducted with a collection of objects and modifying the RBG color on certain objects (or merely presenting a series of random collected objects in the area and measuring the level and/or time at which the patient is capable of identifying the colored object).

Fig. 28 shows that contrast sensitivity can be measured anywhere in the visual

field as opposed to merely on the borders to gain additional information regarding retinal defects. Field contrast sensitivity 96 can be displayed.

Fig. 29 shows that photorecovery time can be measured anywhere in the visual field as opposed to merely on the borders to gain additional information regarding retinal defects. Field contrast sensitivity 97 can be displayed..

The present invention also preferably embodies a pill dispenser with a computer device containing a display screen that a user can interface with, such as a personal digital assistant or PDA.

Figure 30 shows one form of a Pill PDA 100 in which a PDA 60 is attached (as with double-stick tape attached to panel 32 (see Figure 3)) to a pill dispensing device 11. Screen 70 described in conjunction with Figures 11 -29 is shown on the front of PDA 60. In this case the PDA 60 on panel 32 takes the place of grid 43, or could be mounted over grid 43. PDA 60 could be mounted to other packaging including a push-through blister card. This packaging could have holes, for example, which could correspond to posts (not shown) in PDA 60 to attach PDA 60 to the packaging. Pill PDAs could also dispense loose pills, magazines of pills and come in a variety of forms. Pill PDAs provide greater convenience and compliance especially for the elderly. In addition, Pill PDAs are useful for tracking patients' disease progress and pill compliance together. The Pill PDA can record time and date of last dispensing and remind patients via visual, wireless, email, text message, phone call and audible signals if there is a failure to comply. Pill PDAs can be networked to each other, a home computer, and to a patient's doctor for upload of important data to a doctor's office that will permit electronic automatic monitoring of patient information that can be available immediately and from any location. Pill PDAs may contain multiple blister cards for example or disposable dispenser cartridges to coordinate a patient's entire daily regimen of pills.

A touch screen device is shown in Figure 30. However, the screen can be a computer monitor or computer screen instead of a touch screen, with optional voice activation/voice recognition (such as a wireless microphone, such as Bluetooth enabled and that would include voice recognition technology). Such voice activation/voice recognition would enable identification of user responses to letters and/or symbols presented on the screen to measure and/or track a patient's visual acuity at various lighting and visual conditions.

By incorporating an eye-self test with a PDA, the patients' compliance, progress and monitoring can be recorded and the accuracy clinical measurements vastly expanded. Recorded results can be taken more frequently between visits and the results can be viewed by the patient's doctor or eye specialist and allow the specialist to assist in looking for the appearance of wet macular degeneration events or the increase or decrease in the drusen. A home version can be provided to the patient, in a preferred embodiment coupled with a pill dispensing device as described herein. Additional embodiments of such eye tests may also include a photorecovery time function in which a dark screen area is displayed for a sufficient amount of time for a patient's iris to adjust to the dark light and after which a white screen then displayed which gradually fades in increasing contrast an arrow that points to a box and measures the time it takes the patient to correctly see such arrow and identify the box to which the arrow is directed. In a further embodiment, the foregoing arrows presented can be adjusted to various degrees of contrast against the background to also measure changes in patient's contrast sensitivity As described by Sponsol in the patent application describing the Okay test, the game or eye test can be a useful tool in measuring a patient's visual acuity provided a fixed distance from the eye to the screen. As described by Sponsol such that simultaneously measures for visual acuity can be useful for screening potential patients who have suspected macular diseases including all three major retinal eye diseases including macular degeneration and glaucoma, and retinopathy.

Such tests as described herein can also be useful to monitor patient compliance with medications, especially in the elderly, and can be used to evaluate and record memory and cognition (similar to games such as Brain Age by Nintendo), motor skills for movement disorders such as Parkinson's. The devices described herein can also be programmed to automatically remind and/or dispense pills to patients, as well as track compliance. Such benefits are highly useful for use in clinical trials and monitoring of improvement especially with disease modifying therapies targeted at lowering or adjusting patient's free and bound copper levels, free and bound iron levels and free and bound zinc levels, for example. Such testing and dispensing device can record each time it is activated or touched and can be used for clinical trials for web-based including wireless home patient data collection and clinical trial management. By collecting such additional data points, clinical trials of disease modifying therapies such as anticopper

therapies can be evaluated statistically for clinical benefit with smaller patient cohorts, shorter trials and to collect and test new hypotheses in prospectively defined observational or database mining studies for disease causality (such as the Rush University study conducted by Martha Morris regarding copper and Alzheimer's disease). Such additional clinical datapoint and collection can thereby greatly accelerate clinical research and permit much sooner introduction of disease modifying therapies to lower healthcare costs associated with the loss of visual function, memory and cognition, dementia and cardiovascular disease that is currently associated with aging process and vastly improve the health and longevity of humans. Pill containing insert20 can have, for example, a hole (not shown) in each corner thereof which registers with posts (not shown) in container 11 so that the inserts 20 properly register with container 11 when placed therein.

The following is a list of parts and materials suitable for use in the present invention. PARTS LIST

Part Number Description

10 medicine dispensing apparatus

11 package/container

12 side panel 13 side panel

14 end panel

15 end panel

16 bottom panel

17 top panel 18 closure flap

19 eye self-test chart

20 pill containing insert

21 foil layer

22 layer (e.g. PVC, plastic) 23 window/opening

24 pill/medicine

25 void space

26 clear layer

27 magnetic strip

28 adhesive strip

29 tab 30 medicine dispensing apparatus

31 package/container

32 pivotally mounted panel

33 spring hinge

34 frontal portion 35 layer (e.g. PVC, plastic)

36 blister foil layer

37 hard plastic grate layer

38 cavity

39 release lock/closure 40 pill receptive trough

41 projection

42 rear panel

43 eye self-test chart

44 arrow 45 medicine dispensing apparatus

46 package/container

47 interior/void space

48 blister card dispensing wheel

49 front panel/actuator push button 50 eye self-test chart

51 opening

52 collection tray

53 arrow

54 arrow 55 appliance

56 tab

57 panel/surface

58 opening

60 PDA

70 screen

71 cursor 72 box

73 arrow

74 score

75 feedback

76 subtraction 77 visual field grid

78 circle

79 circle

80 circle

81 circle 82 circle

83 circle

84 measurement of contrast sensitivity

90 stylus

91 photorecovery time measurement 92 dark screen area

9 3 shading

94 arrow

95 background

96 field contrast sensitivity 97 field contrast sensitivity

100 pill PDA

All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise. The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.