U.S. patent application number 09/765524 was filed with the patent office on 2001-08-16 for process for maintaining a contact lens.
Invention is credited to Pochet, Arila, Soyer, Patrice.
Application Number | 20010014653 09/765524 |
Document ID | / |
Family ID | 9506572 |
Filed Date | 2001-08-16 |
United States Patent
Application |
20010014653 |
Kind Code |
A1 |
Soyer, Patrice ; et
al. |
August 16, 2001 |
Process for maintaining a contact lens
Abstract
The aqueous maintenance solution according to the invention is
characterized by the presence of an effective amount of
polyethylene glycol 120 methylglucose dioleate. Application: to
aqueous maintenance solutions for hard contact lenses.
Inventors: |
Soyer, Patrice; (Guignes,
FR) ; Pochet, Arila; (Gretz, FR) |
Correspondence
Address: |
Mark B. Wilson
Fulbright & Jaworski L.L.P.
Suite 2400
600 Congress Avenue
Austin
TX
78701
US
|
Family ID: |
9506572 |
Appl. No.: |
09/765524 |
Filed: |
January 19, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09765524 |
Jan 19, 2001 |
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09072790 |
May 5, 1998 |
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6207628 |
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Current U.S.
Class: |
351/159.02 ;
134/42; 427/430.1; 427/443.2; 524/825 |
Current CPC
Class: |
C11D 3/221 20130101;
A61L 12/14 20130101; C11D 1/667 20130101; C11D 3/0078 20130101 |
Class at
Publication: |
510/112 ;
427/430.1; 427/443.2; 351/160.00R; 524/825; 134/42 |
International
Class: |
A61L 012/14; A61L
012/08; B05D 001/00; B08B 003/00 |
Foreign Application Data
Date |
Code |
Application Number |
May 5, 1997 |
FR |
97 05489 |
Claims
1. An aqueous maintenance solution for contact lenses comprising
polyethylene glycol 120 methylglucose dioleate of formula: 2in
which x+y =120.
2. The aqueous maintenance solution of claim 1, wherein the
concentration of polyethylene glycol 120 methylglucose dioleate is
between 0.05 and 5% by weight relative to the total weight of the
solution.
3. The aqueous maintenance solution of claim 1 further comprising a
decontaminating agent.
4. The aqueous maintenance solution of claim 3, wherein the
decontaiminating agent is selected from the group consisting of
chlorhexidine and the water-soluble salts thereof;
polyhexamethylene biguanide and the water-soluble salts thereof;
alkylammonium halides; benzalalkonium halide; quaternary ammonium
salts; and mixtures thereof.
5. The aqueous maintenance solution of claim 4, wherein the
decontaminating agent is a mixture of polyhexamethylene biguanide
or a water-soluble salt thereof and one or more alkylammonium
halides.
6. The aqueous maintenance solution of claim 5, wherein the
alkylammonium halide is cetrimonium bromide.
7. The aqueous maintenance solution of claim 3, wherein the
decontaminating agent represents from 10.sup.-6 to 5% by weight
relative to the total weight of the solution.
8. The aqueous maintenance solution of claim 7, wherein the
decontaminating agent represents from 0.01 to 0.5% by weight
relative to the total weight of the solution.
9. The aqueous maintenance solution of claim 1, further comprising
at least one surfactant chosen from the group consisting of
nonionic, cationic and amphoteric surfactants.
10. The aqueous maintenance solution of claim 1, wherein the
surfactant consists of one or more nonionic surfactants.
11. The aqueous maintenance solution of claim 10, wherein the
nonionic surfactant is a poly(oxyethylene)-poly(oxypropylene) block
polymer.
12. The aqueous maintenance solution of claim 9, wherein the
surfactant represents 0.01 to 15% by weight relative to the total
weight of the composition.
13. The aqueous maintenance solution of claim 12, wherein the
surfactant represents 0.05 to 1% by weight relative to the total
weight of the composition.
14. The aqueous maintenance solution of claim 1, further comprising
water-soluble cellulose polymer.
15. The aqueous maintenance solution of claim 1, further comprising
a sequestering agent.
16. The aqueous maintenance solution of claim 15, wherein the
sequestering agent comprises a compound selected from the group
consisting of ethylenediaminetetraacetic acid, gluconic acid,
citric acid, tartaric acid, the salts of these acids, and
polyphosphate complexes.
17. The aqueous maintenance solution of claim 1, further comprising
a buffer.
18. The aqueous maintenance solution of claim 17, wherein the
buffer is selected from the group consisting of phosphate buffers,
borate buffers, and mixtures thereof.
19. The aqueous maintenance solution of claim 1, further comprising
a tonicity agent.
20. An aqueous maintenance solution for contact lenses comprising:
polyethylene glycol 120 methylglucose dioleate of formula: 3in
which x+y=120; a decontaminating agent; a surfactant; a
sequestering agent; and a buffer.
Description
AQUEOUS SOLUTION FOR MAINTAINING CONTACT LENSES
[0001] The present invention relates generally to an aqueous
solution for maintaining contact lenses, in particular hard contact
lenses.
[0002] Aqueous solutions for maintaining contact lenses generally
have the function of decontaminating and cleaning the lenses.
[0003] To be effective, these solutions need to have a combination
of several properties.
[0004] Firstly, they need to ensure effective decontamination of
the lenses for a broad spectrum of microorganisms, and effective
cleaning of the surfaces of the lenses, without their active
principles being absorbed by the lenses.
[0005] Moreover, in order to simplify the maintenance of lenses, it
is desirable for them to be re-usable directly after soaking in the
maintenance solution, i.e. without it being necessary to carry out
one or more rinses with water. In this case, it is particularly
important, since the maintenance solution must remain in contact
with the user's eye, that this solution is not irritant, is well
tolerated and leaves the lenses comfortable to wear throughout the
period of continuous use, generally a day.
[0006] An important factor for the comfort of use of treated lenses
is the viscosity of the maintenance solution. This viscosity should
not be too low or too high. If the viscosity of the solution is too
low, the solution will not wet the surfaces of the lens correctly;
the user will perceive the lens as a foreign body in the eye, and
if the viscosity is too high, the solution can give rise to cloudy
vision and lead to a greasy feel on the lens, which users find
uncomfortable.
[0007] Another important factor for the comfort of use of lenses
treated with a maintenance solution is the ability of the
maintenance solution to retain a relatively large amount of water
on the surfaces of the lens treated, such that the surfaces of the
lens are humidified throughout a prolonged period and the
wettability of the surfaces of the lens is retained. This
characteristic, which will be denoted hereinbelow as "the
humidity-retaining ability" is an important factor for the user's
comfort. This humidity-retaining ability is a particularly
important factor in the case of hard contact lenses, which
generally have a low ability to retain water on their surfaces.
[0008] In order to improve the wettability of contact lens
surfaces, in particular for hard lenses, it has been proposed to
incorporate hydrophilic monomers into the maintenance solutions.
However, these hydrophilic monomers generally have the drawback of
affecting the other physical properties of the lenses.
[0009] To solve this problem it has also been proposed to
incorporate wetting polymers into the maintenance solutions, but
the action of these polymers is weak and disappears rapidly.
[0010] To overcome the abovementioned drawbacks, document
WO95/00616 proposes adding to the maintenance solutions a
water-soluble poly(ethylene oxide) which is a star polymer
containing a hydrophobic core having at least three carbon atoms
and at least three hydrophilic poly(ethylene oxide) chains (arms)
attached to the core. In addition, the star polymers in document
WO95/00616 must not contain hydrophobic arms attached to the
core.
[0011] In a preferred embodiment of document WO95/00616, a second
surfactant polymer component, a cationic cellulose polymer, is
added to the maintenance solution. This cationic component
complexes with the poly(ethylene oxide) star polymer and the
complex formed is strongly adsorbed onto the surface of the
lenses.
[0012] Although the maintenance solutions of document WO95/00616
are satisfactory, it would be desirable to have available
maintenance solutions which afford the contact lens wearer even
better comfort.
[0013] The object of the present invention is thus to provide a
maintenance solution for contact lenses, in particular for hard
contact lenses, which overcomes the abovementioned drawbacks.
[0014] The subject of the present invention is, more particularly,
a maintenance solution as defined above, which gives treated lenses
improved humidity-retaining ability.
[0015] The subject of the present invention is also a maintenance
solution as defined above, which is easy to use, in particular
which allows treated lenses to be used directly, i.e. without
rinsing, and makes the treated lenses comfortable for the user to
wear.
[0016] The aims listed above are achieved, according to the present
invention, by providing an aqueous maintenance solution for contact
lenses, in particular hard contact lenses, characterized in that it
comprises an effective amount of polyethylene glycol 120
methylglucose dioleate of formula: 1
[0017] in which x+y=120.
[0018] The incorporation of polyethylene glycol 120 methylglucose
dioleate into the maintenance solution not only increases the
wettability of the lenses by the maintenance solution but also
appreciably improves the humidity-retaining ability of the treated
lenses. In addition, the maintenance solutions according to the
invention make the treated lenses particularly comfortable for the
user.
[0019] Preferably, the amount of polyethylene glycol 120
methylglucose dioleate present in the solution is between 0.05 and
5% by weight, better still between 0.1 and 2% by weight, relative
to the total weight of the aqueous maintenance solution.
[0020] As is well known, the aqueous maintenance compositions
according to the invention comprise a decontaminating agent. This
decontaminating agent, generally an antimicrobial agent, is well
known in the art and can consist of a single compound or a mixture
of several compounds. Compounds which are useful as decontaminating
agents can be any known compounds which are useful as
decontaminating agents in aqueous maintenance solutions for contact
lenses.
[0021] Among these compounds, mention may be made of chlorhexidine
(1, 1'-hexamethylenebis[5-(p-chlorophenyl)biguanide]) or
water-soluble salts thereof, such as chlorhexidine gluconate;
polyhexamethylene biguanide (a hexamethylene biguanide polymer also
known under the name polyaminopropyl biguanide) or water-soluble
salts thereof, such as polyhexamethylene biguanide hydrochloride
sold under the trade name Cosmocil CQ.RTM. (ICI Americas Inc.);
alkylammonium halides, in particular alkyltrimethylammmonium
bromides such as tetradecyltrimethylammonium bromide,
dodecyltrimethyl-ammonium bromide, hexadecyltrimethylammonium
bromide (cetrimonium bromide) sometimes known as "Cetrimide";
benzalkonium halides such as benzalkonium chloride; polymeric
quaternary ammonium salts; and mixtures of these compounds.
[0022] The recommended decontaminating agents according to the
invention are polyaminopropyl biguanide and the water-soluble salts
thereof, in particular the product sold under the brand name
Cosmocil CQ.RTM., and alkylammonium bromides, in particular
cetrimonium bromide, and mixtures thereof.
[0023] A decontaminating agent which is particularly preferred
according to the invention is a mixture of polyhexamethylene
biguanide hydrochloride (Cosmocil CQ.RTM.) and cetrimonium
bromide.
[0024] The amount of decontaminating agent in the maintenance
solution according to the invention is an effective amount, i.e. an
amount sufficient to decontaminate lenses. In general, the amount
of decontaminating agent present in the maintenance solution
according to the invention is from 10.sup.-6 to 5% by weight,
preferably 0.01 to 0.05% by weight, relative to the total weight of
the maintenance solution.
[0025] Preferably, the maintenance solutions according to the
invention contain an effective amount of one or more nonionic
surfactants. Among these nonionic surfactants, mention may be made
of fatty acid esters of polyethylene glycol, for example of coconut
oil, polysorbates, polyoxyethylene ethers and polyoxypropylene
ethers of higher alkanes (C.sub.12--C.sub.18). Examples of the
above nonionic surfactants comprise polysorbate 20 (sold under the
brand name Tween 20.RTM.), polyoxyethylene lauryl ether (Brij.RTM.
35), polyoxyethylene (40) stearate (Myrj.RTM. 52), polyoxyethylene
(25) propylene glycol stearate (Atlas.RTM. G 2612).
[0026] A particularly recommended class of nonionic surfactants
comprises poly(oxypropylene)-poly(oxyethylene) adducts of
ethylenediamine and poly(oxyethylene)-poly(oxypropylene) block
polymers.
[0027] The preferred nonionic surfactants are
poly(oxyethylene)-poly(oxypr- opylene) block polymers.
[0028] The maintenance solutions according to the invention
generally contain from 0.01 to 15% by weight of nonionic surfactant
relative to the total weight of the composition, preferably from
0.05 to 1% by weight.
[0029] Preferably also, the recommended
poly(oxyethylene)-poly(oxypropylen- e) block polymer nonionic
surfactant is present in the maintenance solution in an amount such
that the weight ratio between this recommended nonionic surfactant
and the polyethylene glycol 120 methylglucose dioleate is about
1:2.
[0030] Although this is not preferred, the maintenance solution can
also comprise cationic and/or amphoteric surfactants conventionally
used in maintenance compositions for contact lenses, in the usual
proportions.
[0031] The maintenance solutions according to the invention
preferably also comprise one or more standard agents for modifying
the viscosity. These viscosity-modifying agents are well known and
comprise water-soluble cellulose polymers such as hydroxyethyl- or
hydroxypropyl cellulose, carboxymethyl cellulose,
polyvinylpyrrolidone and poly(acrylic acids). The preferred
viscosity-modifying agents are cellulose polymers and in particular
hydroxyethyl cellulose.
[0032] The viscosity-modifying agent is used in the usual amounts,
generally from 0.01 to 4.0% by weight, or less, relative to the
total weight of the solution.
[0033] Besides the polyethylene glycol 120 methylglucose dioleate,
the maintenance solutions according to the invention generally
contain other wetting agents conventionally used in maintenance
solutions for contact lenses, such as poly(oxyethylene) glycols.
These wetting agents are generally present in a proportion of from
0.5 to 5%, preferably 1 to 2% by weight relative to the total
weight of the solution.
[0034] Preferably also, the wetting agent of poly(oxyethylene)
glycol type is present in the maintenance solution in an amount
such that the weight ratio between this recommended wetting agent
and the polyethylene glycol 120 methylglucose dioleate is about
1:1.
[0035] In general, the maintenance solutions according to the
invention comprise one or more sequestering agents (or chelating
agents), in particular for sequestering calcium and magnesium ions,
in an amount which can be up to about 2% by weight relative to the
total weight of the solution. Among the sequestering agents which
can be used in the solutions of the invention, mention may be made
of ethylenediaminetetraacetic acid (EDTA) and its salts, in
particular its sodium salt, polyphosphate complexes such as sodium
hexametaphosphate, sodium pyrophosphate and sodium
tripolyphosphate, gluconic acid, citric acid and tartaric acid and
their salts, in particular their sodium salts. The preferred
sequestering agent is the sodium salt of EDTA.
[0036] The maintenance solutions of the invention also generally
contain a buffer. Among the buffers which can be used in the
maintenance solution according to the invention, mention may be
made of phosphates such as Na.sub.2HPO.sub.4, NaH.sub.2PO.sub.4 and
KH.sub.2PO.sub.4, borate buffers such as boric acid, sodium borate,
potassium tetraborate or potassium metaborate, or mixtures of these
buffers. A recommended buffer is a mixture of monosodium phosphate
and disodium phosphate. The amount of buffer used is generally
between 0.05 and 2.5% by weight, preferably between 1 and 2% by
weight, relative to the total weight of the solution.
[0037] Generally, the tonicity of the aqueous maintenance solutions
according to the invention is adjusted by adding a standard
tonicity agent, such as sodium chloride or a glycerol solution. The
preferred tonicity agent is sodium chloride.
[0038] The maintenance solutions according to the invention can
also contain, in the usual amounts, any other ingredients
conventionally used in maintenance solutions for contact
lenses.
[0039] By way of example of another ingredient which can be
incorporated into the maintenance solutions according to the
invention, mention may be made of germicidal agents such as
thimerosal, sorbic acid, 1,5-pentanediol and phenylmercuric salts
of alkyl thioethanolamines. Such additional germicidal agents are
described in document EP-0 180 309.
[0040] Although the description hereinabove refers mainly to
decontaminating and cleaning solutions, the compound polyethylene
glycol 120 methylglucose dioleate can advantageously be used in
other maintenance solutions for contact lenses, such as storage and
soaking solutions.
EXAMPLES
[0041] An aqueous maintenance solution according to the invention,
having the following composition, was prepared:
1 Polyaminopropyl biguanide 0.001 g (Cosmocil CQ .RTM. 20%
solution) (i.e. 0.0002 g of active principle) Cetrimonium bromide
0.015 g Hydroxyethyl cellulose 0.500 g Polyethylene glycol 120
methylglucose dioleate 1.200 g Poly(oxyethylene)-poly(oxypropylene)
block 0.500 g polymer (Poloxamer) Disodium EDTA 0.065 g
Polyoxyethylene glycol (Macrogol) 1.200 g Buffer of monosodium
phosphate, 2 H.sub.2O and 2.050 g disodium phosphate, 12 H.sub.2O
Sodium chloride 0.160 g Demineralized water qs 100 ml
[0042] The above maintenance solution was compared with commercial
maintenance solutions. In particular, the humidity-retaining
ability of the solutions was determined by working in the following
manner.
[0043] Dry, hard contact lenses are weighed and are then immersed
in each of the test solutions, removed and drained. Each of the
lenses is reweighed and the amount of each solution deposited on
each lens is deduced therefrom. The solutions deposited are left to
evaporate for two hours, the lenses are reweighed and the amount of
components remaining on them is determined. The difference between
the weight of solution initially deposited on the lenses and the
weight of the components remaining on them after two hours of
evaporation is an indication of the humidity-retaining ability of
the solution.
2 TABLE I Commercial maintenance solutions Example Boston .RTM.
Solocare .RTM. 1 Simplicity Hard Totalcare .RTM. pH 7.20 7.26 7.51
7.10 Viscosity-Pa.s .times. 10.sup.-3 (LVI 10 31 15 58 30 t/min at
20.degree. C.) Density 1.016 1.010 1.007 1.010 Weight of solution
remaining 0.0067 0.0048 0.0042 0.0048 on the lens after soaking and
draining (g) Weight of components 0.0006 0.0002 0.0008 0.0005
remaining on the lens after evaporation of the solution (g)
.DELTA.P 0.0061 0.0046 0.0034 0.0043
[0044] The results show that the maintenance solution of the
example shows a 32.6%, 79.4% and 41.8% improvement in the
humidity-retaining ability when compared with commercial
solutions.
[0045] The ocular tolerance conferred by the various solutions
according to the invention, as well as "blank" solutions and
solutions according to Examples 6C and 14A of document WO95/00616
was determined.
[0046] Besides the solution of Example 1, the test solutions were
as follows:
[0047] Comparative Example A: Solution of Example 1 without
Glucamate DOE 120
[0048] Comparative Example B: Solution of Example 1 with 0.1% by
weight of Glucam.RTM. E 20 instead of Glucamate DOE 120
[0049] Comparative Example C: Solution of Example 1 with 1.2% by
weight of Glucam.RTM. E 20 instead of Glucamate DOE 120
[0050] Comparative Example D: Solution of Example 1 with 3% by
weight of Glucam.RTM. E 20 instead of Glucamate DOE 120
[0051] Comparative Example E: Solution of Example 6C of document
WO95/00616 (0.3% Glucam.RTM. E 20)
[0052] Example 2 Solution of Example 6C of document WO95/00616 in
which the Glucam.RTM. E 20 was replaced by 0.3% by weight of
Glucamate DOE 120
[0053] Example 3: Solution of Example 6C of document WO95/00616 in
which the Glucam.RTM. E 20 was replaced by 1.2% by weight of
Glucamate DOE 120
[0054] Comparative Example F: Solution of Example 14A of document
WO95/00616 without Glucam.RTM. E 20 (contains a cationic
surfactant- Polymer JR-30M)
[0055] Comparative Example G: Solution of Example 14A of document
WO95/00616 with 0.02% by weight of Glucam.RTM. E 20
[0056] Example 4: Solution of Example 14A of document WO95/00616 in
which the Glucam.RTM. E 20 was replaced by 0.02% by weight of
Glucamate DOE 120.
[0057] The ocular tolerance was determined by direct instillation
of the solutions into the eyes of a tester, who was asked if he or
she experienced a sensation of eye discomfort.
[0058] The results are indicated in Table II below.
3 TABLE II Ocular Example No. tolerance A X B X C X D X E X F X G X
1 .largecircle. 2 .largecircle. 3 .largecircle. 4 .largecircle.
.largecircle. no sensation of eye discomfort X sensation of eye
discomfort
[0059] The solution of Example 1 was used by 80 contact lens
wearers for a period of 180 days, with medical monitoring.
[0060] Repeated bimicroscopic observations of the wearers' eyes
revealed no manifestation of intolerance to the solution.
[0061] Furthermore, the results with regard to the wettability,
scratches and protein deposits observed by the investigators on the
surface of the lenses show that they are well preserved by the
maintenance solution.
[0062] Lastly, when asked about the efficacy of maintenance, the
comfort when inserting the lenses, the comfort at the end of the
day and ease of use of the maintenance solution of Example 1, 96%
of the individuals tested said that they were satisfied.
[0063] The addition of polyethylene glycol 120 methylglucose
dioleate to maintenance solutions for contact lenses, in particular
hard contact lenses, leads to solutions which make contact lenses
more comfortable to wear by virtue, in particular, of improving the
humidity-retaining ability of these solutions on lenses.
[0064] The combination of polyethyleneglycol 120 methylglucose
dioleate and a nonionic surfactant proves to be particularly
advantageous for obtaining a maintenance solution which is better
tolerated by users.
* * * * *