Claims for Patent: 6,218,428

Summary for Patent: 6,218,428

Title:	Ophthalmic composition
Abstract:	The current invention is an ophthalmic composition that combines multiple agents necessary to perform a routine eye examination. Preferably, the composition is a mixture of a topical local anesthetic, a pupillary dilating agent, and a dye, all in solution. The composition may also include a preservative, a wetting agent, a diluting agent, and/or a buffer. The preferred composition provides a means to: 1) anesthetize the cornea to allow for pain relief, manipulation and the measurement of intraocular pressure, 2) dye the cornea and conjunctiva to allow for the detection of pathology and for the measurement of intraocular pressure, and 3) dilate the pupil to allow for examination of the optic nerve, macula, retina, retinal vasculature, and peripheral fundus. In addition, the invention includes a method of using the inventive composition and a method of using currently available compositions that allow for a more rapid eye examination by eliminating or reducing a waiting period that follows the administration of dilating agents according to the present state of the art. Moreover, the inventive composition may be used pre-operatively before ophthalmic surgery, thereby conferring many of the same advantages as described above.
Inventor(s):	Chynn; Emil (New York, NY)
Assignee:
Application Number:	09/561,465
Patent Claims:	1. An ophthalmic composition comprising a solution mixture of diagnostically acceptable amounts of a local topical anesthetic and a pupillary dilating agent. 2. The composition according to claim 1, wherein the anesthetic is proparacaine, tetracaine, lidocaine, procaine, hexylcaine, cocaine, bupivicaine, benoxinate, mepivacaine, prilocaine, etidocaine, benzocaine, chloroprocaine, propoxycaine, dyclonin, dibucaine, pramoxine, or oxybuprocaine. 3. The composition according to claim 2, wherein the anesthetic is present in an amount of about 0.01% to about 10%. 4. The composition according to claim 1, wherein the pupillary dilating agent is a sympathomemetic agent or a parasympatholytic agent and is present in an amount of about 0.01% to about 15%. 5. The composition according to claim 1, wherein the pupillary dilating agent is phenylephrine, tropicamide, cyclopentolate, hydroxyamphetamine, atropine, or homatropine and is present in an amount of about 0.1% to about 10%. 6. The composition according to claim 1, further comprising a diagnostically acceptable amount of a dye. 7. The composition according to claim 6, wherein the dye is fluorescein, rose bengal, or lissamine green and is present in an amount of about 0.01% to about 10%. 8. The composition according to claim 1, further including a diagnostically acceptable amount of a preservative. 9. The composition according to claim 8, wherein the preservative is benzalkonium chloride in an amount of about 0.0001% to about 0.1%, chlorobutanol in an amount of about 0.1% to about 10%, polysorbate 20 in an amount of about 0.0001% to about 10%, EDTA in an amount of about 0.0001% to about 10%, methylparaben and propylparaben in an amount of about 0.0001% to about 10%, phenylethyl alcohol in an amount of about 0.0001% to about 10%, chlorhexidine in an amount of about 0.0001% to about 10%, or polyaminopropyl biguanide in an amount of about 0.0001% to about 10%. 10. The composition according to claim 1, further including a diagnostically acceptable amount of a wetting agent and a diluting agent. 11. The composition according to claim 10, wherein the wetting agent is carboxymethylcellulose, hydroxypropyl methylcellulose, glycerin, mannitol, polyvinyl alcohol or hydroxyethylcellulose and the diluting agent is water, distilled water, sterile water, or artificial tears, wherein the wetting agent is present in an amount of about 0.001% to about 10%. 12. The composition according to claim 1, further including a diagnostically acceptable amount of a buffer to adjust the pH of the solution between about 4.0 to about 7.5. 13. An ophthalmic composition comprising a diagnostically acceptable amount of a topical local anesthetic, and a pupillary dilating agent, wherein the composition is an ointment, cream, or gel. 14. An ophthalmic composition comprising a solution mixture of diagnostically acceptable amounts of a dye and a pupillary dilating agent. 15. The composition according to claim 14, wherein the dye is fluorescein, rose bengal, or lissamine green in an amount of about 0.01% to about 10%, and the dilating agent is a sympathomemetic agent or a parasympatholytic agent in an amount of about 0.01% to about 15%. 16. The composition according to claim 15, wherein the dilating agent is phenylephrine, tropicamide, cyclopentolate, hydroxyamphetamine, atropine, or homatropine and is present in an amount of about 0.1% to about 10%. 17. The composition according to claim 14, further comprising a diagnostically acceptable amount of a preservative. 18. The composition according to claim 17, wherein the preservative is benzalkonium chloride in an amount of about 0.0001% to about 0.1%, chlorobutanol in an amount of about 0.1% to about 10%, polysorbate 20 in an amount of about 0.0001% to about 10%, EDTA in an amount of about 0.0001% to about 10%, methylparaben and propylparaben in an amount of about 0.0001% to about 10%, phenylethyl alcohol in an amount of about 0.0001% to about 10%, chlorhexidine in an amount of about 0.0001% to about 10%, or polyaminopropyl biguanide in an amount of about 0.0001% to about 10%. 19. The composition according to claim 14, further comprising a diagnostically acceptable amount of a wetting agent and a diluting agent. 20. The composition according to claim 19, wherein the wetting agent is carboxymethylcellulose, hydroxypropyl methylcellulose, glycerin, mannitol, polyvinyl alcohol or hydroxyethylcellulose and the diluting agent is water, distilled water, sterile water, or artificial tears, wherein the wetting agent is present in an amount of about 0.001% to about 10%. 21. The composition according to claim 19, further comprising a diagnostically acceptable amount of a topical local anesthetic and a preservative. 22. The composition according to claim 21, wherein the anesthetic is proparacaine, tetracaine, lidocaine, procaine, hexylcaine, cocaine, bupivicaine, benoxinate, mepivacaine, prilocaine, etidocaine, benzocaine, chloroprocaine, propoxycaine, dyclonin, dibucaine, pramoxine, or oxybuprocaine and is present in an amount of about 0.1% to about 5%, the dye is fluorescein, rose bengal, or lissamine green and is present in an amount of about 0.05% to about 5%, the dilating agent is phenylephrine, tropicamide, cyclopentolate, hydroxyamphetamine, atropine, or homatropine and is present in an amount of about 0.1% to about 10%, the wetting agent is hydroxypropyl methylcellulose and is present in an amount of about 0.1% to about 1%, the preservative is benzalkonium chloride in an amount of about 0.0001% to about 0.1% or chlorobutanol in an amount of about 0.1% to about 10%, and the diluting agent is sterile water. 23. The composition according to claim 21, wherein the anesthetic is proparacaine or tetracaine and is present in an amount of about 0.1% to about 1%, the dilating agent is phenylephrine or tropicamide and is present in an amount of about 0.1% to about 5%, the dye is fluorescein and is present in an amount of about 0.1% to about 1%, the wetting agent is hydroxypropyl methylcellulose and is present in an amount of about 0.1% to about 1%, the preservative is benzalkonium chloride in an amount of about 0.0001% to about 0.1% or chlorobutanol in an amount of about 0.1% to about 10%, and the diluting agent is sterile water. 24. A method of conducting an eye examination comprising the steps of: applying a topical local anesthetic and a dilating agent in combination to the eye; measuring intraocular pressure of the eye after the applying step; and conducting a dilated fundus examination after the measuring step. 25. The method of claim 24, wherein the anesthetic and the dilating agent are applied together from a single solution mixture. 26. The method of claim 24, wherein the step of applying further includes applying a dye to the eye, wherein the anesthetic, the dilating agent and the dye are applied together from a single solution mixture. 27. The method of claim 24, wherein the measuring step is performed by applanation tonometry. 28. A method of treating an eye prior to surgery, comprising the step of applying a topical local anesthetic and a dilating agent to the eye, wherein the anesthetic and the dilating agent are applied together from a single solution mixture. 29. The method of claim 28, wherein the step of applying further includes applying a dye to the eye, wherein the dye, the dilating agent, and the anesthetic are applied together from a single solution mixture.

Details for Patent 6,218,428

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-23