WO1993014792A1

WO1993014792A1 - A disinfecting-cleansing fluid and moisturising fluid for contact lenses and their use

Info

Publication number: WO1993014792A1
Application number: PCT/FI1992/000025
Authority: WO
Inventors: Mauno Sakari Reiala
Original assignee: Mauno Sakari Reiala
Priority date: 1992-01-30
Filing date: 1992-01-30
Publication date: 1993-08-05
Also published as: AU1202392A; EP0588795A1

Abstract

A disinfecting-cleansing fluid for contact lenses composed of as such known art c. two percent solution of boracic acid eye lotion or equivalent, into which c. 0.001 - 0.002 % or c. 10 - 20 mg/l of oxygen has been dissolved using an as such known art method, such as blowing of air. Its use is such that, at the time of the user first opening the eyes, drops of it or equivalent fluid are dropped onto contact lenses meant to be permanently kept on the eyes. The disinfecting-cleaning fluid may be formed to act as the moisturiser fluid for contact lenses, such as may be used when viewing television programmes in the evenings, so that the fluid contains as such known art eye moisturising fluid whose active components are: Duasorb, benzalkon.chloride 0.01 % and sod.edet. 0.05% or equivalent moisturiser fluid, c. 10 - 40 %, and so that the moisturiser fluid is cleaned off the lenses in accordance with claim 2 or an equivalent manner. A drop bottle for the aforementioned fluids may as such be formed of a known art disposable syringe or equivalent so that the syringe is filled with the said or equivalent fluid in the course of factory manufacturing or equivalent.

Description

A disinfecting-cleansing fluid and moisturising fluid for contact lenses and their use

The objects of the invention are a disinfecting-cleansing fluid and a moisturising fluid for contact lenses and their use.

When a contact lens is worn overnight on the eye, the lens's surface pores become void and the lens harden. Surprisingly, it has been observed that this is of no consequence to the eye if a solution, such as a boracic acid solution, is added to the eye in conjunction with it being opened for the first time after sleeping. Similarly, it has been observed that oxygen dissolved in a solution of boracic acid is retained in the pores of the contact lenses and that it has a beneficial effect on the eye throughout the day.

Pollutants and dirt from the air, bacteria, and harmful proteins from lacrimal fluid come into contact with the lens, and a state of oxygen deficiency affecting the eye tends to develop under the lens. For these reasons, it has been necessary to daily disinfect and neutralise contact lenses, and to rinse and remove the protein from them by means of various kinds of relatively expensive substances and to impose strain on the eyes by the removal and replacement of lenses requiring a relatively high level of skill and with these maintenance measures taking relatively long to carry out.

A known art disinfectant used in the aforementioned maintenance of contact lenses is a hydrogen peroxide solution of about three percent. This substance irritates the eye and it must always be neutralised and removed from the lens by means of a separate neutralising agent during a maintenance stage that takes about ten minutes to carry out.

The disadvantage is that small amounts of the said substance are retained in the lens pores. The neutralisation and the lens maintenance necessary because of the possible remnants of storage substances in the lens must be performed daily. The experience with lenses worn overnight is that the user is unable to see with the dry lenses because of the reduced nighttime secretion of lacrimal fluid. The practice has been for contact lenses to be removed for the night and to be stored in a container of storage fluid. A contact lens is a partial obstacle to the entry of oxygen to dissolve into the lacrimal fluid behind the lens and attempts have been made to avoid this problem by manufacturing lenses to be of 55 - 70 percent porosity instead of the known art 40 percent porosity. Neverthe¬ less, the problem of oxygen depletion has only worsened when special lenses of such high liquid content have been worn continuously for about two weeks without daily disinfecting- cleansing being performed. Medical studies have shown that the oxygen deficiency formed underneath contact lenses causes eye ailments such as inflammation of the cornea or keratitis. In addition, the risk of eye disorders caused by contact lenses has been heightened by the following factors. The daily procedure of putting the lenses in position has irritated the cornea of the eye. Particles of dirt and bacteria have been introduced onto the user's eyes when contact lenses are put in position. Bacteria and particles of dirt that have been sucked into the rinsing fluid bottle have been transferred onto the lenses and from there onto the user's eyes. Tiny amounts of hydrogen peroxide have been transferred with the lenses onto the eyes. Another inconvenience connected to contact lenses has been the experience that they are not so well suited for older and busy people. They have been troublesome to wear in dusty conditions and in sports that induce heavy perspiration. In both of these situations the lenses have to be occasionally removed for cleansing purposes and this is bothersome.

Known art boracic acid solution disinfects the eyes and is composed of sterile water containing boracic acid, collyrium boricum (2 percent or 20 mg/ml) and phenylhydrarg.nitr. 0.01 mg/ml. Oxygen may be dissolved in water just like it can be dissolved in a solution of boracic acid in the same manner as is used with indoor aquariums by blowing bubbles of air into it. The lens of the eye has no blood veins and gets its nourishment from the surrounding chamber fluid. Fish in an aquarium do well when a continuous stream of air is blown into the water so that the oxygen concentration in the water is about 10-20 mg/1. Contact lens storage fluid for storing soft contact lenses in a container is known on the basis of EP patent application 95524. The said storage fluid contains relatively large amounts of sodium chloride, boracic acid and borax as is required by container storage. No oxygen has been dissolved in the said storage fluid.

A cleansing-rubbing solution for the purpose of removing deposits from the surfaces of hard and soft contact lenses is known on the basis of EP patent application 279 378. This substance contains small particles that remove dirt. The solution may as such contain boracic acid along with many other substances. This solution must not come into contact with the eyes.

FI patent 62463 describes a method whereby the hydrogen peroxide is disintegrated from contact lenses disinfected in a container by means of the same treatment by hydrogen peroxide and the said hydrogen peroxide is then removed using a catalyst made of metals. The solution containing the catalyst must not come into contact with the eyes.

Sterilising of contact lenses in a container of water containing ozone (0₃) and with the device containing an ozonesator is known on the basis of DE patent application 3524407. The water containing ozone or an abundance of oxygen must not come into contact with the eyes because of their irritation-inducing nature.

FI patent publication 85816 describes the contact lens disinfec¬ ting-cleansing fluid and how it is used.

Contact lenses do not always remain sufficiently moist. Nighttime TV viewing is an example of a situation in which the lenses tend to become dry. There are known art moisturising substances for eyes. A moisturising fluid is an example of these. The said fluid's active components are: Duasorb, benzalkon.chloride 0.01 % and sod.edet. 0.05 %. This moistu¬ rising fluid forms a thin membrane or equivalent over the lens surface and it also prevents the lens from drying. Nevertheless, a disadvantage with moisturising fluids has been the fact that the said fluid enters the pores in the lenses and lenses become less clear because of lack of disinfecting- cleansing fluid that would also clean the surface pores of the lenses. Now that the new disinfecting method means that the pores in the lenses become partially void during the night and then in the morning they fill up again with the mildly disinfec¬ ting fluid, moisturising fluids no longer collect into the surface pores of the lenses.

Since the cornea of the eye is no longer irritated by the daily putting into position of the contact lenses, and since there is no longer hydrogen peroxide to be retained in contact lens pores, and since dirty air is no longer sucked into bottles of rinsing fluid and bacteria are thus eliminated from coming into contact with contact lenses, and since disinfecting of the lenses now takes place by the lens pores being partially evacuated and then being refilled with mildly disinfecting fluid, and since oxygen deficiency underneath the lenses is reduced, the wearing of contact lenses results in less or no risk at all of eye ailments such as keratitis as compared to the situation before.

The purpose of the invention is to bring about such a disinfec¬ ting-cleansing fluid for contact lenses as will enable contact lenses to be daily disinfected and cleaned and any protein contained by them to be removed without the user ever needing to remove the lenses from the eyes, and so that all the afore¬ mentioned contact lens disadvantages as well the possible risk of the lenses causing eye ailments can be minimised or altoget¬ her eliminated.

The purpose of the invention is to bring about the use of the disinfecting-cleansing fluid.

A further purpose of the invention is also to bring about an improved moisturising fluid suitable for contact lenses and the use of the said fluid.

Yet another purpose of the invention is to bring about such a drop bottle for the aforementioned fluids as will not suck in unclean air.

The above purposes are achieved in accordance with the characte¬ ristics of the invention defined in the patent claims.

The disinfecting-cleansing fluid in accordance with the invention is as follows:

It is composed of a 2 percent solution of as such known art boracic acid solution eye lotion into which oxygen has been dissolved using a method as such of known art so that the oxygen content in the said solution is c. 0.001 - 0.002 % or c. 10 - 20 mg/1. The use of the fluid for disinfecting and cleansing of and removing of protein from contact lenses without it being necessary for the lens to be removed from the eyes is such that drops of the said fluid are caused to fall onto contact lenses kept permanently on the eyes at the moment the user opens his/her eyes on awakening.

The disinfecting-cleansing fluid may be composed to function as the moisturising fluid for contact lenses. An example of such use is in the evening so that the said fluid contains as such known art eye moisturising fluid whose active components are: Duasorb, benzalkon.chloride 0.01 %, sod.edet. 0.05 %, or equivalent, c. 10 - 40 %, and it is cleaned away from contact lenses in accordance with claim 2.

The drop bottle for the said fluids or equivalent can be formed of as such known art disposable syringe or equivalent so that the syringe is filled with the said fluid or equivalent in the course of factory manufacturing or equivalent and so that it is provided with a stopper or equivalent.

An example:

The disinfecting-cleansing fluid for contact lenses was made by blowing as such known art medical inhalation air through a gas sterilising filter into a 2 % solution of boracic acid eye lotion. The amount of oxygen dissolved in the liquid came to be c. 0.002 %. Examples of other gases contained by the inhalation air and dissolved into the liquid were nitrogen and argon.

The contents of the disinfecting-cleansing fluid:

Distilled water 1 ml, acid.boricum 20 mg, phen lhydrarg.nitr.

0.01 mg, dissolved oxygen c. 0.002 %.

The contact lenses were as such known art hydrophilic polymer lenses with 62 % phemfilcon A and 38 % water.

The contact lenses were worn continuously on the eyes for a period of over a year and even further without the lenses being removed during the period. The disinfecting-cleansing of the contact lenses was carried out according to user instructions.

The results were monitored under the supervision of a doctor.

Results:

The fluid dropped onto the eyes in the morning filled the partially evacuated lens pores and the lens base during the night and disinfected and cleansed the lens on all sides and softened the lens into normal softness within c. 4 seconds. Lenses that were in place continuously, and did not become twis¬ ted, adapted to the eye better than those in the former method in which they were removed and then replaced again. No disadvantages such as changes in parameters or scratched surfaces or dirt in lens pores were observed to be connected to the continuous use of the lenses.

Visibility through the lenses was good in the morning and through the day and through the entire year.

Conclusion:

Contact lenses such as those used in the example, for example, can be worn on the eyes continuously for a period of one year by using a disinfecting-cleansing fluid in accordance with the patent claim in the manner described in the user instructions. The results obtained so far indicate that a person can wear contact lenses in this manner for his entire lifetime.

Claims

CLAIMS :

1. A disinfecting-cleansing fluid, characterised in that it is as such a known art c. two percent solution of boracic acid eye lotion, or equivalent, into which c. 0.001 - 0.002 % or c. 10 -20 mg/1 of oxygen has been dissolved using a as such known art method, such as blowing of air.

2. The use of a fluid as claimed in claim 1 for the purpose of disinfecting and cleansing of and removing of protein from contact lenses worn over the eyes, characterised in that drops of disinfecting-cleansing fluid or equivalent as claimed in claim 1 are dropped onto contact lenses intended to be per¬ manently kept over the eyes at the moment when the eyes are first opened.

3. A fluid as claimed in claim 1, characterised in that it has been formed for the purpose of being a moisturising fluid for contact lenses to be used, for example, in the evenings so that it contains as such known art eye moisturiser fluid whose active components are: Duasorb, benzalkon.chloride 0.01 % and sod.edet. 0.05 %, or equivalent moisturiser fluid, c. 10 - 40 %, and the moisturiser fluid is cleaned off the lenses in accordance with claim 2.

4. A drop bottle for a fluid in accordance with claim 1 and/or claim 3, characterised in that it is formed of as such known art disposable syringe or equivalent so that the syringe is filled with a fluid in accordance with claim 1 and/or 3 or equivalent fluid in the course of factory manufacturing or equivalent and that it is provided with a stopper or equivalent.