The invention is directed to contact lens cases, and in particular, to the delivery of ophthalmic active agents to the eyes by means of contact lenses.
Current methods of delivering ophthalmic active agents, i.e., both pharmaceutical and non-pharmaceutical agents, to treat ocular disorders and diseases are somewhat inefficient and cumbersome. For example, ninety percent of current ophthalmic active agents are provided in drops or ointments, which typically have low absorption rates. In fact, usually less than seven percent of the applied active agent is absorbed by eye tissue. Due to low absorption rates, drops and ointments must include high dosages of active agent(s), and multiple dosages often must be applied in order for the active agent(s) to be effective. Additionally, side effects, such as heart problems, can result when using eye drops because the active agent(s) in the drops can seep into the nasal cavity and then into the bloodstream and other tissues.
Convenience for the patient, and consequently, patient compliance in administering the ophthalmic agents is also an issue to be considered. For example, a person may need to transport one or more containers (such as bottles or tubes) containing eye drop solution or eye ointment to ensure that appropriate treatments are applied at specific times during a day. Also, the person will likely have to administer the drops every two to four hours because of the low absorption rates and tear wash out. Not only is this an inconvenience, but the person may forget or miss one or two treatments each day.
It is therefore desirable to provide a more effective and convenient system for delivering ophthalmic active agents to the eye. More specifically, it is desirable to provide a system that delivers ophthalmic agents to the eye via a contact lens.
Contact lens cases for delivering ophthalmic agents to contact lenses are described. The ophthalmic agents are then delivered to the eyes by the way of the contact lenses as the agents are introduced to the contact lenses prior to insertion. According to one embodiment, a contact lens case comprises a container defining a reservoir for holding a contact lens solution and a contact lens, and a first lid assembly for attachment to the container. The lid assembly includes a lid attachable to the container for closing the reservoir, and a dispenser pack that is attachable top the lid. The dispenser pack comprises at least one compartment containing a treatment unit for dispensing into the reservoir. The reservoir would also contain a lens solution. The treatment unit is dispensed into the reservoir for mixing or dissolving into the solution. A contact lens is allowed to soak in the reservoir to absorb or retain at least a portion of the solution and a quantity of an ophthalmic agent from the treatment unit. The contact lens is subsequently placed on an eye for administering at least some of the ophthalmic agent to an eye for treatment.
According to another embodiment, a contact lens case includes a container defining a reservoir for holding a solution and a contact lens, and a one-piece lid for attachment to the container and closing the reservoir. The lid includes at least one compartment containing a treatment unit for dispensing into the reservoir and delivery of a quantity of an ophthalmic agent from the treatment unit to the contact lens.
Another embodiment includes a contact lens case with two containers and two lid assemblies or lids corresponding to the two containers, thereby enabling the storage of two contact lenses and the treatment of two eyes at the same time.
Another embodiment includes a contact lens kit includes a contact lens case and multiple dispenser packs containing treatment units. The packs are individually attachable to the lid(s) of the case, thereby allowing dispenser packs that have been depleted of treatment units to be replaced without replacing the case.
According to further embodiments, a contact lens kit includes a case having multiple lids containing treatment units. The lids are individually attachable to the container(s) of the case, thereby allowing lids that have been depleted of treatment units to be replaced without replacing the entire case.
Further features and advantages of the invention will be apparent upon reference to the following description, appended drawings, and claims.
A contact lens case 10 according to one embodiment is illustrated in
Still referring to
Referring to
According to alternate embodiments (not shown), the threads 46 on the lid 40 and the threads 28 on the lid engaging portion 26 of the container 20 may be eliminated, and the lid 40 may be configured to fit onto the lid-engaging portion 26 by being pressed or snapped onto the lid engaging portion 26 with an interference or friction fit.
As shown in
Each compartment 56 contains a treatment unit 8 contained in its interior volume 60. The patterns of weakness 59 facilitate rupturing of the bottom walls 58 to dispense the treatment units 8 from the compartments 56.
The pack 50 may further include an annular gasket 51 positioned at the outer periphery of the pack 50 for providing a seal between the lid 40 and the container 20. The gasket 51 may cover portions of the upper and lower sheets of material 52, 54 and/or the outer peripheral edge of the pack 50. The gasket 51 may be constructed of a resilient material such as rubber, silicone, or plastic, for example.
Referring to
Once the lid assembly 30 is assembled, the lid assembly 30 may be threaded or pressed (where the lid 40 and container 20 are threadless) onto the container 20 after the solution 4 and the contact lens 6 are placed in the reservoir 2 in order to close the case 10 and prepare the case 10 for delivering a quantity of a treatment agent from a treatment unit 8 to the contact lens 6. A treatment unit 8 may be individually dispensed from a compartment 56 by pressing the top wall 57 of the compartment 56 downward (in direction D, shown in
It should be noted that the treatment unit 8 may also be dispensed from a compartment 56 prior to securing the lid assembly 30 to the container 20, while the lid 40 is detached and from the container 20 and held thereabove.
Treatment units 8 may be administered to the contact lens 6 in the above-described manner at daily intervals, or at any other prescribed intervals, depending on the form and composition of the unit 8 and the condition being treated. In order to remind a user when a treatment is due, the lid 40 and/or dispenser pack 50 may include treatment identifiers or labels I (
The described contact lens cases can also be one component of a drug delivery kit. For example, a kit would include a case 10 and a plurality of packs 50 such as four packs containing seven compartments 56. The four packs would provide one month of eye treatments before the case 10 is discarded and replaced. Proper hygiene is promoted by limiting the number of packs 50, and therefore the number of eye treatments, provided with the case 10. It should be understood, however, that any number of packs 50 may be provided, and each pack 50 may be provided with any number of compartments 56, as desired.
A plurality of internal threads 246 are provided on an internal surface 245 of the side wall 244, and are designed to engage the external threads 28 of a container 20 as described the in the embodiments of
The top wall 242 includes a plurality of compartments 256 defined by the upper and lower sheets of material 252, 254. Each of the compartments 256 may contain a treatment unit 8 that can be dispensed from the compartment 256. The upper sheet of material 252 defines the top walls 257 of the compartments 256, and the lower sheet of material 254 defines the bottom walls 258 (see
The lid 240 is a one-piece alternative to the lid assemblies 30, 130 described above with respect to
A unit 8 can be dispensed from a compartment 256 in the same way a unit 8 is dispensed from a compartment 56 in the previous embodiments. Specifically, pressing down on the top wall 257 in the direction D will force the top wall 257 and the unit 8 downward and thereby rupture the bottom wall 258 of the compartment 256. To help ensure proper administration of treatments, the lid 240 may also include treatment identifiers or labels I (
A lid assembly 30 may be attached to each container 620 in the same manner described with respect to the container 20 in the embodiment of
The treatment units 8 to be administered to contact lenses 6 according to the various embodiments disclosed herein can be in powder, tablet, liquid or liquid emulsion form, and can contain any ophthalmic agent or compound that is used to treat any ocular disease or any ocular condition. Accordingly, the agent(s) in the units 8 can be selected from any class of compounds, for example, anti-inflammatory agents, anti-infective agents (including antibacterial, antifungal, antiviral, antiprotozoal agents), anti-allergic agents, antiproliferative agents, anti-angiogenic agents, anti-oxidants, neuroprotective agents, cell receptor agonists, cell receptor antagonists, immunomodulating agents, immunosuppressive agents, IOP lowering agents (anti-glaucoma), beta adrenoceptor antagonists, alpha-2 adrenoceptor agonists, carbonic anhydrase inhibitors, cholinergic agonists, prostaglandins and prostaglandin receptor agonists, AMPA receptor antagonists, NMDA antagonists, angiotensin receptor antagonists, somatostatin agonists, mast cell degranulation inhibitors, alpha-2 adrenoceptor antagonists, thromboxane A2 mimetics, protein kinase inhibitors, prostaglandin F derivatives, prostaglandin-2 alpha antagonists and muscarinic agents. It should be understood that while each of the units 8 may comprise the same active agent(s), it is possible to provide different active agents in individual units 8, as desired.
Of particular interest are pharmaceutical active agents that are known to treat an ocular disease or disorder including, but not limited to, a posterior-segment disease or disorder. In certain embodiments, such disease or disorder typically may include diabetic retinopathy, diabetic macular edema, cystoid macular edema, age macular degeneration (including the wet and dry form), optic neuritis, retinitis, chorioretinitis, intermediate and posterior uveitis and choroidal neovascuralization.
Glaucoma is a group of diseases that are characterized by the death of retinal ganglion cells (“RGCs”), specific visual field loss, and optic nerve atrophy. Glaucoma is the third leading cause of blindness worldwide. An intraocular pressure (“IOP”) that is high compared to the population mean is a risk factor for the development of glaucoma. However, many individuals with high IOP do not have glaucomatous loss of vision. Conversely, there are glaucoma patients with normal IOP. Therefore, continued efforts have been devoted to elucidate the pathogenic mechanisms of glaucomatous optic nerve degeneration.
It has been postulated that optic nerve fibers are compressed by high IOP, leading to an effective physiological axotomy and problems with axonal transport. High IOP also results in compression of blood vessels supplying the optic nerve heads (“ONHs”), leading to the progressive death of RGCs. See; e.g., M. Rudzinski and H. U. Saragovi, Curr. Med. Chem.—Central Nervous System Agents, Vol. 5, 43 (2005).
Pharmaceutical active agents that are prescribed by a physician for the treatment of glaucoma, and that may be formulated and disposed in the compartmentalized lens case for delivery to a contact lens and subsequently to the eye of a patient include travoprost, brimonidine, levobunolol, epinephrine, bitmatoprost, dipivefrin, carteolol and metipranolol.
In one embodiment, the anti-glaucoma pharmaceutical agent is of general formula II
wherein A and Q are independently selected from the group consisting of aryl and heteroaryl groups substituted with at least a halogen atom, cyano group, hydroxy group, or C1-C10 alkoxy group; R1, R2, and R3 are independently selected from the group consisting of unsubstituted and substituted C1-C5 alkyl groups; B is a C1-C5 alkylene group; D is the —NH or —NR′— group, wherein R′ is a C1-C5 alkyl group; and E is the hydroxy group.
Exemplary, pharmaceutical agents of general formula II include A as a dihydrobenzofuranyl group substituted with a fluorine atom; Q as a quinolinyl or isoquinolinyl group substituted with a methyl group; R1 and R2 are independently selected from the group consisting of unsubstituted and substituted C1-C5 alkyl groups; B is a C1-C3 alkylene group; D is the —NH— group; E is a hydroxy group; and R3 is a trifluoromethyl group.
Exemplary compounds include a glucocorticoid receptor agonist having Formulae III or IV, as disclosed in US Patent Application Publication 2006/0116396.
wherein R4 and R5 are independently selected from the group consisting of hydrogen, halogen, cyano, hydroxy, C1-C10 (alternatively, C1-C5 or C1-C3) alkoxy groups, unsubstituted C1-C10 (alternatively, C1-C5 or C1-C3) linear or branched alkyl groups, substituted C1-C10 (alternatively, C1-C5 or C1-C3) linear or branched alkyl groups, unsubstituted C3-C10 (alternatively, C3-C6 or C3-C5) cyclic alkyl groups, and substituted C3-C10 (alternatively, C3-C6 or C3-C5) cyclic alkyl groups.
Compositions of the invention also include ocular formulations prescribed by or recommended by a physician, or a health care provider, to treat ocular allergic conditions. Allergy is characterized by a local or systemic inflammatory response to allergens. Allergic conjunctivitis is a disorder that is characterized by the clinical signs and symptoms of eye itching, redness, tearing, and swelling. An estimated 20% of the population in the United States suffer from inflammation of the eye. The signs and symptoms of allergic conjunctivitis can significantly impact the quality of life of patients, from social interactions, productivity at work and school, to the ability to perform visual tasks such as working on a computer or reading.
Currently, available pharmaceutical treatments for inflammation of the eye or symptoms of inflammation of the eye include (1) antihistamines, (2) drugs that block the release of histamine and other substances from a mast cell (e.g., mast cell stabilizers), (3) drugs with multiple modes of action (e.g. antihistamine/mast cell stabilizing agents), and (4) drugs that can actively constrict blood vessels thus reducing redness and swelling (e.g., vasoconstrictors). Additionally, artificial tears have been used to wash the eye of allergens.
The desirability of a particular treatment for inflammation of the eye can be measured against the following factors (1) efficacy at onset of action, (2) duration of action, (3) efficacy at controlling signs and symptoms of allergic conjunctivitis, and (4) comfort of the drop when instilled in the eye.
Pharmaceutical active agents that are prescribed by a physician for the treatment of an ocular allergic condition, and that may be formulated and disposed in the compartmentalized lens case for delivery to a contact lens and subsequently to the eye of a patient include olopatadine, nedocromil, and lotepdrenol.
In one embodiment, the pharmaceutical active agent is ketotifen or a salt thereof. Ketotifen or any ophthalmically acceptable ketotifen salt may be used in the compartmentalized lens case herein described, although ketotifen fumarate is preferred. Ketotifen fumarate is represented by the following formula:
In another embodiment, the pharmaceutical active agent is an anti-redness agent, which may relieve redness in the eye. The preferred anti-redness agent is naphazoline or an ophthalmically acceptable salt thereof such as, for example, naphazoline hydrochloride. Other anti-redness agents that may be used include, but are not limited to, tetrahydrozoline, ephedrine, phenylephrine, oxymetazoline, xylometazoline, pseudoephedrine, tramazoline, other vasoconstrictors, combinations thereof, as well as ophthalmically acceptable salts thereof (e.g., tetrahydrozoline hydrochloride).
Naphazoline hydrochloride is represented by the following formula:
Naphazoline or a naphazoline salt may be present in a concentration from about 0.001% to about 0.2% (or alternatively, from about 0.001% to about 0.1%). In one embodiment, naphazoline or a naphazoline salt is present in a composition at a concentration from about 0.01% to about 0.1%; preferably, from about 0.01% to about 0.07%; more preferably, from about 0.02% to about 0.06%. In some embodiments, the method provides stability to compositions comprising naphazoline or a naphazoline salt in a concentration such that the concentration of naphazoline in the composition is about 0.02% to about 0.05%. Concentrations of a naphazoline salt yielding such concentrations of naphazoline base may be readily calculated; for example, using naphazoline hydrochloride in a concentration of about 0.025% in the composition provides a concentration of naphazoline base in the composition of 0.021%.
Additional information on formulations containing ketotifen, naphazoline or a corresponding pharmaceutically salt of each thereof can be found in U.S. patent application Ser. No. 10/972,571 filed Oct. 25, 2004.
Pharmaceutical active agents that are prescribed by a physician for the treatment of an ocular infection, and that may be formulated and disposed in the compartmentalized lens case for delivery to a contact lens and subsequently to the eye of a patient include antimicrobial agents, antibiotic agents and antifungal agents. The antimicrobial agents are selected from the group consisting of ciprofloxacin, sulfacetamide, trimethoprin, polymyxin B and norfloxacin. The antibiotic agents are selected from the group consisting of natamycin, tobramycin, gentamicin, gatifloxacin and ofloxacin. One of the more preferred antfungal agents is cromolyn.
Pharmaceutical active agents that are prescribed by a physician for the treatment of ocular inflammation, and which are formulated and disposed in the compartmentalized lens case for delivery to a contact lens and subsequently to the eye of a patient include stearoidal anti-inflammatory agents including dexamethasone, prednisolone, fluormetholone, medrysone, flurbiprofen and loteprednol. Alternatively, a non-steroidal anti-inflammatory agent such as ketorolac can be used with the compartmentalized lens case.
In yet another embodiment, cyclosporine can be formulated into stable emulsions and disposed in the compartmental lens case herein described. Cyclosporine is an immunosuppressive agent that is prescribed to patients with an ocular infection associated with keraconjunctivitis sicca. The cyclosporine is believed to act as a partial immunomodulator and enhances tear production.
In yet another embodiment, pharmaceutical active agents of the FK506 class can be formulated into stable emulsions and disposed in the compartmental lens case herein described. Emulsions, since they contain an aqueous phase, are much less occlusive than oil-based compositions and hence are better tolerated in many situations. Accordingly, in one embodiment a formulation, in the form of an emulsion, comprises a compound of the FK506 class, and a physiologically acceptable alkanediol, ether diol or diether alcohol containing up to 8 carbon atoms as solvent. A compound of the “FK506 class” is a compound which has the basic structure as FK506 and which has at least one of the biological properties of FK506 (e.g., immunosuppressant properties). The compound may be in free base form or pharmaceutically acceptable, acid addition, salt form. A preferred compound of the FK 506 class is disclosed in EP 427 680, e.g. Example 66a (also called 33-epi-chloro-33-desoxyascomycin).
In other embodiments, the agent(s) in treatment units 8 may include non-pharmaceutical ocular agents. For example, the units 8 may comprise agents such as lens rewetting agents, lubricating agents, moisturizing agents, alginate, HA [?], comfort agents, etc. The units 8 may also include disinfectant powders or tablets with rapid dissolution.
The foregoing disclosure provides illustrative embodiments and is not intended to be limiting. It should be understood that modifications of the disclosed embodiments are possible within the spirit and scope of the invention, and the invention should be construed to encompass such modifications.