Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-04-28
2001-04-17
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S540000, C514S912000
Reexamination Certificate
active
06218428
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to diagnostic ophthalmic compositions and a method of administering those compositions during routine eye examinations. In particular, the inventive compositions, which preferably contain a local anesthetic, a dye and a dilating agent, perform multiple functions, including: 1) anesthetizing the cornea to allow for pain relief, manipulation and the measurement of intraocular pressure (“IOP”), 2) dying the cornea to allow for the detection of pathology and the measurement of IOP, and 3) dilating the pupil to allow for examination of the optic nerve, macula, retina, retinal vasculature, and peripheral fundus (“dilated exam”). These compositions may also include a preservative, a wetting agent, a diluting agent, and/or buffers. The method of administering these ophthalmic compositions enables the physician to perform more efficient eye examinations. The compositions may also be used to perform similar functions prior to ophthalmic surgery.
2. Background
A routine eye examination typically consists of three basic components: 1) examination of the front structures of the eye; 2) measurement of IOP; and 3) examination of the optic nerve, macula, retina, retinal vasculature, and peripheral fundus (the “dilated fundus exam”). The current state of the art consists of sequentially administering multiple topical agents to a patient's eye in order to perform the multiple components of the examination. This sequence is described as follows:
First, a topical anesthetic agent, usually proparacaine or tetracaine, is applied to the eyes to anesthetize the cornea and allow for visualization and manipulation. Next, a fluorescein strip (or other acceptable dye) is applied to the tear film as a disclosing agent to reveal pathology, such as corneal abrasions or ulcers. The application of topical anesthesia and fluorescein is followed by the measurement of IOP by applanation tonometry, which is the method most commonly used by clinicians to measure IOP. After the cornea is examined and IOP is measured, a topical dilatipg agent is usually instilled to dilate the pupil, thereby permitting dilated fundus exam by direct and/or indirect ophthalmoscopy. The dilating agents used are typically sympathomemetic agents, parasympatholytic agents, or both. After instilling the dilating agent(s), the doctor and patient must wait approximately twenty minutes to allow for adequate pupillary dilation in order to conduct the dilated fundus exam (the “waiting time”). The waiting time is an extremely inefficient part of the routine eye examination according to the current state of the art.
Diagnostic ophthalmic compositions currently exist which combine some, but not all, of the above components to allow for some, but not all, of the necessary functions for a complete eye exam. For example, a combination of benoxinate hydrochloride (a topical anesthetic agent) and fluorescein sodium (a dye) is currently available (by Akom, Inc., of Decatur, Ill.). This combination provides anesthesia to the patient's eye and simultaneously stains the cornea to allow for corneal examination and IOP measurement. Another currently available combination anesthetic/dye is FLUORACAINE® solution, also by Akom, Inc. This combination agent includes proparacaine hydrochloride as the anesthetic and fluorescein sodium as the dye. However, even with the use of these currently available combination agents, after measuring IOP, according to the current state of the art, the doctor must still apply one or more dilating agents and allow for the waiting time to elapse before performing a dilated fundus examination.
Other formerly available combination agents combine two dilating agents, specifically a sympathomemetic agent and a parasympatholytic agent. For example, a combination of phenylephrine and tropicamide, and a combination of tropicamide and hydroxyamphetamine were formerly available. Notwithstanding all of the above-mentioned commercially available combination agents, at least two distinct compositions are required according to the current state of the art for a complete eye examination—a combination anesthetic-dye drop applied before IOP measurement, and a dilating agent or combination dilating agent applied after IOP measurement. Thus, with the current state of the art, multiple drops are still required and the inefficient waiting time is still a necessary part of the examination to allow for sufficient pupillary dilation. It would be advantageous to eliminate the multiple eye drops necessary for a complete eye examination, as well as provide a method of administration which eliminates or greatly reduces the waiting time, thereby maximizing efficiency and minimizing patent discomfort.
SUMMARY OF THE INVENTION
The present invention relates to diagnostic ophthalmic compositions that contain various agents necessary to perform an eye examination. Preferably, the composition includes a topical local anesthetic, a dilating agent, and a dye. The composition may also include a preservative, a wetting agent, a diluting agent, and/or a buffer. The composition provides a means to: 1) anesthetize the front structures of the eye, allowing for their examination and manipulation, 2) dye the cornea and conjunctiva, allowing for the detection of pathology, 3) accurately measure IOP, and 4) dilate the pupil for dilated fundus exam. In addition, the method of administering the inventive composition allows for a more rapid and efficient eye examination because the waiting period necessary according to the present state of the art can be greatly reduced and, in most cases, even eliminated.
Using the composition, a complete eye examination may often be performed after instilling a single composition at the beginning of the examination. The composition thus saves time and cost, while minimizing patient discomfort and the inventory needed for conducting eye examinations. Alternatively, the various components that comprise the inventive composition can be administered separately or in different combinations, all before measuring IOP, resulting in many of the same advantages as administering a single combination composition.
An embodiment of the inventive composition may also be used preoperatively before ophthalmic surgery (e.g., cataract surgery). In this regard, the composition will anesthetize the eye and provide for rapid and complete dilation. It has the added benefit of dying the eye to mark it for the operation to help prevent inadvertent surgery on a healthy fellow eye.
DETAILED DESCRIPTION OF THE INVENTION
A. Composition Components
One embodiment of the current invention is an ophthalmic composition that contains multiple agents necessary to perform a complete eye examination, often with a single instillation of the composition at the beginning of the examination. Preferably, the composition includes a local anesthetic, a dye, and a dilating agent. The composition may also include a preservative, a wetting agent, and a diluting agent. Administering the composition performs many of the functions necessary for a complete eye exam, including: 1) anesthetizing the front structures of the eye, allowing for their examination and manipulation, 2) dying the cornea and conjunctiva with a dye, allowing for the detection of pathology, 3) allowing accurate IOP measurement, and 4) dilating the pupil for dilated fundus eye exam.
The composition should contain a diagnostically acceptable amount of each desired component. A diagnostically acceptable amount is an amount that will perform the necessary function within the context of the eye examination and not cause undue interference or side effects that render the composition ineffective or unduly problematic for use in an eye examination. Routine tests, such as the clinical studies described in more detail hereinafter, and other tests and studies known to those skilled in the art will help determine the proper amounts and concentrations of each component. When describing a specific amount of each component, the concentrations of
Fay Zohreh
Pennie & Edmonds LLP
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