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WO1997011722A1 - Desinfection et nettoyage de lentilles de contact - Google Patents

Desinfection et nettoyage de lentilles de contact Download PDF

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Publication number
WO1997011722A1
WO1997011722A1 PCT/DK1996/000404 DK9600404W WO9711722A1 WO 1997011722 A1 WO1997011722 A1 WO 1997011722A1 DK 9600404 W DK9600404 W DK 9600404W WO 9711722 A1 WO9711722 A1 WO 9711722A1
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WO
WIPO (PCT)
Prior art keywords
protease
tablet
contact lenses
disinfecting solution
cleaning
Prior art date
Application number
PCT/DK1996/000404
Other languages
English (en)
Inventor
Thomas Lykke SØRENSEN
Flemming Mark Christensen
Original Assignee
Novo Nordisk A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Priority to AU70836/96A priority Critical patent/AU698356B2/en
Priority to JP9513090A priority patent/JPH11512834A/ja
Priority to EP96931760A priority patent/EP0999857A1/fr
Priority to CA002231845A priority patent/CA2231845A1/fr
Publication of WO1997011722A1 publication Critical patent/WO1997011722A1/fr
Priority to US09/022,135 priority patent/US5919698A/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/12—Non-macromolecular oxygen-containing compounds, e.g. hydrogen peroxide or ozone
    • A61L12/124—Hydrogen peroxide; Peroxy compounds
    • A61L12/126—Hydrogen peroxide; Peroxy compounds neutralised with catalase or peroxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/12—Non-macromolecular oxygen-containing compounds, e.g. hydrogen peroxide or ozone
    • A61L12/124—Hydrogen peroxide; Peroxy compounds

Definitions

  • the present invention relates to a one-step method for disin ⁇ fecting and cleaning contact lenses of the type using hydrogen peroxide as the disinfecting agent, a protease as the cleaning agent and a catalase for neutralizing the hydrogen peroxide in the aqueous disinfecting solution.
  • the invention relates to a tablet or capsule suitable for one-step disinfection and cleaning, a one-step disinfection and cleaning system and further a one-step procedure for disin- fection and cleaning contact lenses.
  • contact lenses have been improved during the last decades and posses many advantages in comparison to glasses, contact lenses still need to be disinfected and cleaned period ⁇ ically, in most cases every day, to avoid infections and discomfort for the wearer.
  • Disinfection prevent growth of bacteria on the surface of the contact lenses which might lead to infection of the eyes and making it impossible to wear contact lenses for days.
  • Cleaning is normally performed by an enzyme capable of degrad- ing debris and/or soil build up on the contact lenses surface. These deposits reduce the wearing comfort as only a reduced amount of oxygen is capable of penetrating the contact lenses to the eyes, and as the friction between the eyes and the contact lenses is increased.
  • the contact lenses need to be rinsed thoroughly to remove all enzymatic activity and/or disinfecting agent, e .g. by using a physi ⁇ ological saline solution.
  • Catalases E.C. 1.11.1.6 are enzymes which catalyze the conversion of hydro ⁇ gen peroxide (H 2 O 2 ) to water (H 2 O) and oxygen (0 2 ) .
  • CA 1,146,881 (Bedding) concerns a method for cleaning contact lenses using enzymes, where the cleaning procedure is followed by rinsing of the lenses, e .g. with saline, to remove active enzymes from the lens.
  • US patent no. 4,670,178 (Allergan) discloses a method for simultaneous cleaning and disinfection of contact lenses with a protease in hydrogen peroxide. The cleaning is effected by presence of protease activity and shown to be very efficient. After the cleaning and disinfection procedure the activity of the disinfecting and cleaning agent need to be removed from the lenses before use.
  • EP patent application no. 147,100 (Ciba Geigy) concerns clean ⁇ ing and disinfection of contact lenses with a hydrogen peroxide solution in the presence of a solid sustained release composi ⁇ tion which slowly releases a peroxide inactivator.
  • the lenses may be treated with a wetting or comfort solution before inserting into the eyes.
  • cleaning and disinfection with hydrogen peroxide does not remove proteinaceous deposits effectively from the surface of the contact lenses.
  • WO 86/07264 describes a method for disinfection and cleaning of contact lenses with hydrogen peroxide using a catalase immobilized in a container for neutralization of the hydrogen peroxide. This way excess hydrogen peroxide is decomposed without washing and rinsing.
  • WO 93/17721 (Genencor Int. Inc.) describes an improved method for cleaning and disinfection of contact lenses comprising disinfection with hydrogen peroxide and decomposition of the residual hydrogen peroxide in the solution with catalase enzyme (CatR) derived from the filamentous fungus Aspergillus niger.
  • CatR catalase enzyme
  • WO 95/02044 (Novo Nordisk A/S) concerns two acidic proteases active in the presence of hydrogen peroxide in concentrations up to as high as 5 wt.%.
  • Example 5 of said application de ⁇ scribes cleaning and disinfection of contact lenses using one of said acidic proteases as the cleaning agent and hydrogen peroxide as the disinfecting agent. Further, it is mentioned that catalase may be used for neutralization of the hydrogen peroxide .
  • a one-step disinfecting and cleaning systems for contact lenses would in ⁇ crease the safety and consumer convenience.
  • the object of the present invention is to facilitate the daily troublesome task of disinfecting and cleaning contact lenses and to make the task more safe to perform.
  • the invention relates to a one-step method for disinfection and cleaning of contact lenses comprising the steps: a) disinfection of the contact lenses in an aqueous disin- fecting solution comprising from 1 wt.% to 5 wt.% hydrogen peroxide at a pH not acceptable to the eyes, b) cleaning the contact lenses by subjecting the contact lenses to a protease being inactivated within a period of time at a pH level not acceptable to the eyes, c) neutralization of the hydrogen peroxide in the aqueous disinfecting solution with a microbial catalase being substan ⁇ tially active at pH 3.0 to 7.0, d) adjusting the pH in the aqueous disinfecting solution to a pH level acceptable to the eyes.
  • the invention also relates to a tablet or capsule for disin ⁇ fection and cleaning of contact lenses, wherein the tablet is a multi-layer tablet, comprising i) a protease being irreversibly inactivated within a period of time in an aqueous disinfecting solution at a pH level not ac ⁇ ceptable to the eyes, and ii) a microbial catalase being substantially active at pH 3.0 to 7.0, iii) an agent capable of adjusting the disinfecting solution to a pH acceptable to the eyes.
  • the invention is also directed toward a one-step system for disinfection and cleaning of contact lenses comprising a) an aqueous disinfecting solution comprising 1 wt.% to 5 wt.% hydrogen peroxide, and b) a tablet or capsule comprising i) a protease being irreversibly inactivated within a period of time in the aqueous disinfecting solution at a pH level not acceptable to the eyes, and ii) a microbial catalase being substantially active at pH 3.0 to 7.0, i ⁇ ) an agent capable of adjusting the aqueous disinfecting solution to a pH acceptable to the eyes.
  • the invention relates to a one-step procedure for disinfection and cleaning of contact lenses, comprising the steps of
  • the object of the present invention is to facilitate the daily troublesome task of disinfecting and cleaning contact lenses and to make the task more safe to perform.
  • disinfection and cleaning of contact lenses is of the type involving the steps: a) disinfection of the contact lenses in an aqueous solution comprising between 1 wt.% and 5 wt.% hydrogen peroxide, espe ⁇ cially 3 wt.% hydrogen peroxide, and b) cleaning the contact lenses with a protease to remove debris and/or soil, and c) neutralization of the hydrogen peroxide in the aqueous disinfecting solution with a catalase.
  • the present inventors have solved some of the problems of prior art disinfecting and cleaning systems by providing a more safe consumer convenient system.
  • a more safe and consumer convenient disinfecting and cleaning system means that the system, in comparison to corresponding prior art systems using the same above mentioned principles, have at least one of the following the following the following advantages: - reduces or eliminates the risk of using the system incorrectly (i.e. the system is more safe to use) ; facilitates the disinfection and cleaning task for the contact lens user (i.e. more easy to use); - reduces the amount of steps to be performed by the contact lens user (i.e. less work to be done and less time are needed to perform the disinfection and cleaning task) .
  • the present invention can be used for disinfection and cleaning of all types of contact lenses including hard, soft, rigid gas permeable lenses and silicone lenses etc..
  • the basic principle of the present invention is to use a suit ⁇ able protease which is inactivated in the aqueous disinfecting solution during cleaning, due to e . g . pH influence, temperature influence or the like. Before being completely inactivated the protease must have had sufficient time and sufficient enzyme activity to clean the contact lenses. It is to be understood that it is within the scope of the invention to use the disinfection and cleaning principle of the invention for corresponding disinfecting and cleaning proce- dures including separate disinfecting and cleaning (i.e. two- step methods) .
  • the invention relates to a one-step method for disinfection and cleaning of contact lenses comprising the steps: a) disinfection of the contact lenses in an aqueous disinfec ⁇ ting solution comprising from 1 wt.% to 5 wt.% hydrogen per ⁇ oxide at a pH not acceptable to the eyes, b) cleaning the contact lenses by subjecting the contact lenses to a protease being inactivated within a period of time at a pH level not acceptable to the eyes, c) neutralization of the hydrogen peroxide in the aqueous dis ⁇ infecting solution with a microbial catalase being substanti ⁇ ally active at pH 3.0 to 7.0, d) adjusting the pH in the aqueous disinfecting solution to a pH level acceptable to the eyes.
  • a pH level not acceptable to the eyes means in the context of the present invention a pH within the ranges from about pH 8.0 to 13.0 and within the range about pH 1.0 to 6.0.
  • a pH level acceptable to the eyes means a pH within the range from between about pH 6.0 to 8.0.
  • aqueous disinfecting solution is a conventional commercial disinfecting solution comprising about 3 wt.% hydrogen peroxide at pH 3.5 (e.g. Oxysept®l from Allegan) .
  • one-step disinfection and cleaning means that the contact lens user's task consists of one continuous step only, which can be per ⁇ formed within few seconds and without any additional steps before the contact lenses are ready to wear.
  • the combined daily disinfection and cleaning makes the recom ⁇ mended weekly cleaning superfluous, as the amount of build-up debris and/or soil on the contact lenses' surfaces are dimin- ished considerably.
  • the daily disinfection and cleaning results in improved wearing comfort.
  • all the present protease activity must be irreversibly inactivated within a fixed period of time to be defined.
  • the protease in question is to be irreversib ⁇ ly inactivated within a very short period of time the amount of protease must be relatively large to ensure cleaning of the contact lenses before complete inactivation of the protease. If, in contrast hereto, the protease in question is to be inactivated very slowly over a longer period of time only a very little amount of protease is needed.
  • the inactivation period for the protease may be from about 1 to 10 minutes to about 1, 2, 3 and no more than 4 hours.
  • a reduced amount of protease is needed when cleaning daily in comparison to cleaning weekly.
  • the optimal amount of active protease to be added to the aqueous disinfecting solution to effectively clean the contact lenses before all protease activity has been inactivated by pH inactivation can easily be determined by a person skilled in the art.
  • Contemplated amounts of protease lies in the range from 0.5 ⁇ g to 50 ⁇ g preferably 1 ⁇ g to 25 ⁇ g, especially 2 ⁇ g to 10 ⁇ g enzyme protein/ml.
  • the protease used according to the invention may be any neu ⁇ tral, acidic or alkaline protease being irreversibly inac ⁇ tivated within a period of time (see above) in a disinfecting solution at a pH not acceptable to the eyes.
  • the pH of the aqueous disinfecting solution should be acidic in order to irreversible inactivate the protease.
  • Suitable proteases can be ⁇ elected from the group comprising serine proteases, aspartic proteases, cysteine proteases and metallo proteases.
  • serine proteases examples include tryp ⁇ ins, chymo- trypsins and alkalophilic subtilisins.
  • Bacillus derived alkaline serine pro ⁇ teases such as subtilisin A, subtilisin BPN', subtilisin Carlsberg, subtilisin PB92, subtilisin 309, subtilisin 147, subtilisin 168, subtilisin DY, aqualysin or thermitase, trun- cations, modification and variants thereof.
  • cysteine proteases examples include papain and bro elain.
  • metallo proteases e . g . Neutrase® and collagenase.
  • aspartic proteases are e .g. pepsin A, pepsin B, pepsin C, chymosin, cathepsin B and renin.
  • Bovine liver catalases have normally been chosen for neutral- ization of hydrogen peroxide solutions for disinfection of con ⁇ tact lenses.
  • BSE Bovine Spongiform Encephalopathy
  • microbial catalases such as catalases deri ⁇ vable from bacteria, filamentous fungi or yeasts.
  • microbial catalases such as e . g. the micro ⁇ bial catalases mentioned below, are better at acidic pHs in comparison to "standard" bovine liver catalase. Consequently it is advantageous to use microbial catalases for neutralization of hydrogen peroxide in disinfecting solutions for contact lenses with an acidic pH.
  • Catalases derived from the filamentous fungus Aspergillus niger have even been shown to posses prop- erties which makes them superior to bovine liver catalases.
  • Catalase-A CatA
  • Catalase-R CatR
  • CatR is four time as effective than "standard" bovine liver catalase in application requiring neutralization of a concentrated hydrogen peroxide solution. In other words CatR neutralizes hydrogen peroxide in conventional disinfecting solution (i.e. 3 wt.% H 2 ⁇ , pH 3.5) much faster than standard bovine liver catalase. Further, CatR is more stable than bovine liver catalase toward proteolysis, extreme pH, temperature, hydrogen peroxide and inactivation by glu ⁇ taraldehyde, SDS, etc. (see WO 93/17721 from Genencor) . Furthermore, CatR is substantially active at pH in the presence of 3 wt.% hydrogen peroxide from at least pH 3.0 and 7.0, while the activity of conventional bovine liver catalase decreases drastically from pH 7.0 toward pH 3.0.
  • a microbial catalase being substantially active at pH 3.0 to 7.0, preferably at pH 3.0 to 4.5, may advantageously be used for neutralization of hydrogen peroxide in aqueous disinfecting solutions for contact lenses together with a protease being irreversibly inactivated within a period of time in the disin ⁇ fecting solution at a pH not acceptable to the eyes.
  • Example 1 shows that Subtilisin A is a such suitable protease.
  • a catalase being substantially active at pH 3.0 to 7.0, preferably 3.0 to 4.5, defines a catalase having a relative enzymatic activity within said pH-ranges (pH-optimum defines 100%) higher than 60%, better 70%, even better more than 80%, such as 90%, and in the best case up to about 100%.
  • the combination secure that the one-step method of the invention results in a fast and efficient disinfection of the contact lenses, as the protease removes the soil matrix in which the bacteria (to be killed by the hydrogen peroxide) are present. Consequently, due to this the accessibility for the hydrogen peroxide to the bacteria is very good.
  • the microbial catalase may advantageously be any of the cata ⁇ lases mentioned above, such as an Aspergillus niger catalase, in particular CatR.
  • the microbial catalase may also be the Aspergillus niger catalase disclosed by Novo Nordisk A/S in 1990 for neutraliza ⁇ tion of hydrogen peroxide in aqueous disinfecting solutions for contact lenses.
  • the best mode of the present invention is obtained by combining the serine protease subti ⁇ lisin A (available from Novo Nordisk as Cleanlens®Pro) , as the protease, and the A. niger catalase named CatR described in WO 93/17721, as the microbial.
  • the protease will be irreversibly inactivated at a pH level in the range between 1.0 to 4.5 within a suitable period of time.
  • the agent capable of adjusting the pH in the aqueous disinfect- ing solution may be any suitable agent acceptable to the eyes.
  • the pH adjusting agent may be a buffer, an acid or a base.
  • the purpose of the pH adjustment is to secure that the contact lenses safely can be entered directly from the aqueous disin ⁇ fecting solution into the eyes, without any risk of damaging the eyes.
  • a suitable buffer may be selected from the group of buffers including alkali metal salts, such as potassium or sodium carbonates, acetates, borates, sodium or potassium phosphates, citrates, and hydroxides, and weak acids such as acetic and boric acids.
  • alkali metal salts such as potassium or sodium carbonates, acetates, borates, sodium or potassium phosphates, citrates, and hydroxides
  • weak acids such as acetic and boric acids.
  • the invention relates to a tablet, capsule or the like which uses the principles of the method of the invention.
  • the optimal way to introduce the protease, catalase, and pH adjusting agent into the aqueous disinfecting solution is in the form of a tablet or the like, it is to be understood that also other embodiments have been contemplated by the inventors and should be regarded as encom ⁇ passed by the scope of the present invention.
  • the protease, catalase and pH adjusting agent may be added to the aqueous disinfecting solution as liquids or a combination of liquids and solids.
  • a multi layer tablet constructed for one-step disinfection and cleaning of contact lenses comprises i) a protease being irreversibly inactivated within a period of time in an aqueous disinfecting solution at a pH not acceptable to the eyes, and ii) a microbial catalase being substantially active at pH 3.0 to 7.0, iii) an agent capable of adjusting the aqueous disinfecting solution to a pH acceptable to the eyes.
  • the tablet may have any suitable embodiment. Four suitable embodiments will be described as examples below. The action of the four embodiments of the tablet (i.e. A, B, C and D) , when used for one-step disinfection and cleaning, will also be described below.
  • the multi-layer tablet A comprises a) an outer layer or coating comprising said microbial catalase being substantially active at pH 3.0 to 7.0, and b) a layer within said outer layer comprising a protease being irreversibly inactivated within a period of time in an aqueous disinfecting solution at a pH level not acceptable to the eyes, and c) an agent capable of adjusting the disinfecting solution to a pH acceptable to the eyes.
  • the multi layer tablet B comprises a) an outer layer or coating comprising a protease being irreversibly inactivated within a period of time in an aqueous disinfecting solution at a pH level not acceptable to the eyes, and b) a layer within said outer layer comprising said microbial catalase being substantially active at pH 3.0 to 7.0, and c) an agent capable of adjusting the disinfecting solution to a pH acceptable to the eyes.
  • the multi layer tablet C comprises a) an outer layer or coating comprising a protease being irreversibly inactivated within a period of time in an aqueous disinfecting solution at a pH not acceptable to the eyes, b) a layer within said outer layer comprising an agent capable of adjusting the disinfecting solution to a pH acceptable to the eyes, and c) a core comprising a microbial catalase being substantially active at pH 3.0 to 7.0.
  • the multi layer tablet D comprises a) an outer layer or coating comprising a protease being irreversibly inactivated within a period of time in an aqueous disinfecting solution at a pH not acceptable to the eyes and a microbial catalase being substantially active at pH 3.0 to 7.0, and b) a core comprising an agent capable of adjusting the aqueous disinfecting solution to a pH acceptable to the eyes.
  • the protease and microbial catalase may be any of the above mention proteases and catalases.
  • the broad pH activity level of the microbial catalase is advantageous as adjustment to a precise pH in an aqueous disinfecting solution becomes less crucial, which again render the strict and timely control of the release of the catalase layer in the tablet less important.
  • Said pH adjusting agent may be any suitable agent, such as a buffer or an acid or a base which is capable of adjusting the pH in the aqueous disinfecting solution to a level acceptable to the eyes.
  • the core and layers of the multi tablet may be separated by a barrier or a membrane.
  • Said barrier may in an embodiment of the invention be made of a water soluble polymer layer, preferably a water soluble film.
  • water soluble film comprises polymers soluble in an acidic medium, such as polymers of dimethylamino ethacry- late and neutral methacrylate esters.
  • the film comprises a pH neutral soluble polymer.
  • Suitable polymers are e .g. soluble cellulose ethers, such as methylcellulose, methylhydroxycellulose , methylhydroxyethyl ⁇ cellulose, hydroxypropylcellulose, hydroxypropyimethylcellu ⁇ lose, hydroxyethylcellulose, sodium carboxymethylcellulose, cellulose acetate phthalate, hydroxypropyimethylcellulose phthalate, a polymer of methacrylic acid and methacrylate esters, a copolymer of methacrylic acid and methacrylate esters, a copolymer of methyl vinyl ether and maleic acid anhydride and polyvinyl alcohols.
  • soluble cellulose ethers such as methylcellulose, methylhydroxycellulose , methylhydroxyethyl ⁇ cellulose, hydroxypropylcellulose, hydroxypropyimethylcellu ⁇ lose, hydroxyethylcellulose, sodium carboxymethylcellulose, cellulose acetate phthalate, hydroxypropyimethylcellulose
  • the tablet comprises a sparingly soluble core and one or two outer layers having the active constituents dispersed or distributed.
  • Suitable plasticizers of polyhydric alcohols and water may be added to the above listed soluble film polymers to control the diffusion rate.
  • Preferred plasticizers for this purpose are 1,2-propylene glycol, polyethylene glycols and citrate esters.
  • the tablet is a controlled release tablet of the type where the content in the outer layer is first released followed by content in the second layer after a period of time, and finalized by the release of the core content after a period of time. One of or both layers or the core content may be released slowly.
  • the release time of the pH adjusting agent should be so long that the protease has sufficient time to degrade composites on the contact lenses' surface.
  • the neutralization ability of the catalase is not dependent on the action of the pH adjusting agent.
  • the content in the second layer and/or core content is(are) released delayed to the aqueous disinfecting solution.
  • Additional components may be added to or incorporated into the tablet or capsule which do not substantially decrease the activity of the active components.
  • Examples are components such as effervescing agents, stabi ⁇ lizers, chelating agent and/or sequestering agents, colouring agent, tonicity adjusting agents, surfactant and the like.
  • binders, lubricants, carriers, and other excipients normally used in producing tablets may be incorporated.
  • Effervescing agents are typically employed when the enzymes are provided in solid form.
  • suitable effervescing agent include, tartaric or citric acid used in combination with suitable alkali metal salts, such as sodium carbonate.
  • the tablet of the invention is to be used in an aqueous disinfecting solution it may contain one or more of suitable chelating agents and/or sequestering agent, tonicity adjusting agent and surfactant.
  • Suitable tonicity adjusting agents include sodium and potassium chloride, dextrose, calcium and magnesium chloride.
  • Suitable surfactants can either be cationic, anionic, nonionic or amphoteric. Preferred surfactants are neutral or nonionic.
  • polyethylene glycol ethers of fatty acids polyoxypropylene ethers of C12-C18 alkanes and polyxye- thylene, polyoxypropylene block copolymers of ethylene diamine (i.e. poloxamine) .
  • EDTA Ethylenediami ⁇ netetraacetic acid
  • salts sodium
  • polyvinyl alcohols examples include Ethylenediami ⁇ netetraacetic acid (EDTA) and its salts (disodium) and certain polyvinyl alcohols.
  • the tablet of the invention constitutes together with an aqueous disinfecting solution comprising 1 wt.% to 5 wt.% hydrogen peroxide a one-step disinfecting and cleaning system for contact lenses.
  • An ideal consumer convenient disinfection and cleaning pro- cedure is carried out in only one continuous step, e.g. in connection with storing the contact lenses for the night, resulting in that the contact lenses are ready for wearing directly from the storage container the next morning without any additional work.
  • the contact lens user only need to introduce the contact lenses into a fix amount of an aqueous disinfecting solution comprising hydrogen peroxide and add a tablet the invention.
  • Said tablet perform the cleaning and disinfection task and further neutralizes the hydrogen peroxide in a safe manner. Consequently, the one-step system of the invention reduces the work to be done for the contact lens user when performing the disinfecting and cleaning task; facilitates the disinfecting and cleaning task, as only one continuous step need to be performed; eliminates the risk of using the system incorrectly, (e .g. forgetting to neutralize the contact lenses after disin ⁇ fection and/or cleaning before wear) , as the procedure can be performed continuously within few seconds.
  • the one-step system of the invention comprises a) an aqueous disinfecting solution comprising 1 wt.% to 5 wt.% hydrogen peroxide, and b) a tablet or capsule comprising i) a protease being irreversibly inactivated within a period of time in an aqueous aqueous disinfecting solution at a pH not acceptable to the eyes, and ii) a microbial catalase being substantially active at pH 3.0 to 7.0 for neutralizing the hydrogen peroxide, and iii) an agent capable of adjusting the pH in the aqueous disinfecting solution to a pH level acceptable to the eyes.
  • hydrogen peroxide is present in the aqueous disinfecting solution in 3 wt.% (pH 3.5) .
  • the tablet or capsule of the invention may advantageously be used as a constituent in the one-step system of the invention.
  • the contact lenses are immersed in a conventional 3 wt.% hydrogen peroxide disinfecting solution (pH 3.5) together with multi layer tablet A.
  • a conventional 3 wt.% hydrogen peroxide disinfecting solution pH 3.5
  • the microbial catalase (comprised in the outer layer) is released leading to neutralization of the hydrogen peroxide in the aqueous disinfecting solution.
  • the protease (comprised in the layer below the outer layer) is released into the disinfecting solution and the contact lenses are cleaned.
  • the prote ⁇ ase is irreversibly inactivated.
  • the buffer (comprised in the core of the tablet) is released resulting in that the pH increases to a pH acceptable to the eyes.
  • the contact lenses are ready to wear directly from the aqueous disinfecting solution.
  • the contact lenses are immersed in a conventional 3 wt.% hydro- gen peroxide disinfecting solution (pH 3.5) together with multi layer tablet B. Initially the hydrogen peroxide disinfects the contact lenses. The protease (comprised in the outer layer) is released into the disinfecting solution and cleans the contact lenses. Within a period of time the protease is irreversibly inactivated. After a period of time the microbial catalase
  • the buffer (comprised in the core of the tablet) is released increasing the pH to a level acceptable to the eyes.
  • the lenses are ready to wear directly from the aqueous disinfecting solution.
  • the contact lenses are immersed in a conventional 3 wt.% hydro- gen peroxide disinfecting solution (pH 3.5) together with multi layer tablet C.
  • a conventional 3 wt.% hydro- gen peroxide disinfecting solution pH 3.5
  • the hydrogen peroxide disinfects the contact lenses.
  • the protease (comprised in the outer layer) is released into the disinfecting solution and cleans the contact lenses.
  • the buffer (comprised in the layer below the outer layer) is released resulting in that the pH is increased to a level acceptable to the eyes.
  • the catalase (comprised in the core of the tablet) is released resulting in neutralization of the hydrogen peroxide in the aqueous disinfecting solution.
  • the lenses are ready to wear directly from the aqueous disinfecting solution.
  • the contact lenses are immersed in a conventional 3 wt.% hydrogen peroxide disinfecting solution (pH 3.5) together with multi layer tablet D. Initially the hydrogen peroxide disin- fects the contact lenses. The protease and the microbial catalase (comprised in the outer layer) are released into the disinfecting solution. The contact lenses are cleaned by the protease and the hydrogen peroxide is neutralized by the catalase. Within a period of time the protease is irreversibly inactivated. After a period of time the buffer (comprised in the core of the tablet) is released resulting in that the pH is increased to a level acceptable to the eyes. The lenses are ready to wear directly from the aqueous disinfecting solution.
  • pH 3.5 3 wt.% hydrogen peroxide disinfecting solution
  • the catalase in contrast to bovine liver cata- lase is active at pH 3.5 the catalase can neutralize the hydrogen peroxide at the same time as the protease cleans the contact lenses.
  • the invention relates to a one-step procedure for disinfecting and cleaning contact lenses, comprising the steps of
  • the aqueous disinfecting solution must constitute a fixed amount which will normally be between 1 ml and 10 ml, especial ⁇ ly about 5 ml.
  • step 3 The storage period needed in step 3) depend of the formulation.
  • the tablet is formulated so that the contact lenses must be stored for between 10 minutes and 12 hours, preferably between 15 minutes and 4 hours, especially between 20 minutes and 2 hours.
  • Subtilisin A (available from Novo Nordisk as Cleanlens®Pro) ,
  • the proteolytic activity may be determined with denatured hemoglobin as substrate.
  • Anson-Hemoglobin method for the determination of proteolytic activity denatured hemoglobin is digested, and the undigested hemoglobin is precipitated with trichloroacetic acid (TCA) .
  • TCA trichloroacetic acid
  • the amount of TCA soluble product is determined with phenol reagent, which gives a blue color with tyrosine and tryptophan.
  • One Anson Unit is defined as the amount of enzyme which under standard conditions (i.e. 25°C, pH 7.5 and 10 min. reaction time) digests hemoglobin at an initial rate such that there is liberated per minute an amount of TCA soluble product which gives the same color with phenol reagent as one milliequivalent of tyrosine.
  • the pH-stability of Subtilisin A (available from Novo Nordisk as Cleanlens®Pro) was determined by letting an enzyme solution (0.0003 AU/ml) stand for between 0 to 240 minutes, at 25°C and different pH-values (from pH 2 to 7) and measure proteolytic activity before and after standing.
  • Subtilisin A is stable at pH 7 in the absence of H 2 O 2 .
  • Table 2 shows that Subtilisin A is very unstable at pHs from below 7.

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  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un procédé intégré de désinfection et de nettoyage de lentilles de contact, qui consiste à utiliser de l'eau oxygénée comme agent désinfectant et une protéase comme agent de nettoyage, selon les étapes suivantes: a) désinfection des lentilles de contact dans une solution aqueuse désinfectante comprenant, en poids, de 1 à 5 % d'eau oxygénée, à un pH non acceptable pour les yeux, b) nettoyage des lentilles de contact par exposition à une protéase inactivée pendant un certain temps à un pH non acceptable pour les yeux, c) neutralisation de l'eau oxygénée dans la solution aqueuse désinfectante avec une catalase microbienne sensiblement active à un pH compris entre 3 et 7, d) correction du pH dans la solution aqueuse désinfectante afin d'atteindre un niveau acceptable pour les yeux. On décrit par ailleurs un comprimé ou une capsule qui se prête à l'opération simultanée de désinfection et de nettoyage, un système de désinfection et de nettoyage simultanés, et une procédure de désinfection et de nettoyage simultanés des lentilles de contact.
PCT/DK1996/000404 1995-09-25 1996-09-24 Desinfection et nettoyage de lentilles de contact WO1997011722A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU70836/96A AU698356B2 (en) 1995-09-25 1996-09-24 Disinfection and cleaning of contact lenses
JP9513090A JPH11512834A (ja) 1995-09-25 1996-09-24 コンタクトレンズの消毒及び洗浄
EP96931760A EP0999857A1 (fr) 1995-09-25 1996-09-24 Desinfection et nettoyage de lentilles de contact
CA002231845A CA2231845A1 (fr) 1995-09-25 1996-09-24 Desinfection et nettoyage de lentilles de contact
US09/022,135 US5919698A (en) 1995-09-25 1998-02-11 Disinfection and cleaner of contact lenses

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DK107095 1995-09-25
DK1070/95 1995-09-25
DK1168/95 1995-10-16
DK116895 1995-10-16

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US09/022,135 Continuation US5919698A (en) 1995-09-25 1998-02-11 Disinfection and cleaner of contact lenses

Publications (1)

Publication Number Publication Date
WO1997011722A1 true WO1997011722A1 (fr) 1997-04-03

Family

ID=26065170

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK1996/000404 WO1997011722A1 (fr) 1995-09-25 1996-09-24 Desinfection et nettoyage de lentilles de contact

Country Status (6)

Country Link
EP (1) EP0999857A1 (fr)
JP (1) JPH11512834A (fr)
CN (1) CN1197397A (fr)
AU (1) AU698356B2 (fr)
CA (1) CA2231845A1 (fr)
WO (1) WO1997011722A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998037921A3 (fr) * 1997-02-28 1998-12-17 Albert Sturm Produit d'entretien pour lentilles de contact
US6241973B1 (en) * 1997-01-03 2001-06-05 Ari Rinne Method and product for cleaning and/or whitening of teeth
WO2016085066A1 (fr) * 2014-11-28 2016-06-02 ㈜지엔케미컬 Composition d'enrobage de comprimés désinfectants et procédé de préparation de comprimés désinfectants enrobés par l'utilisation de celle-ci
US9427488B2 (en) 2009-06-29 2016-08-30 Menicon Co., Ltd. Disinfection system of contact lens

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101664043B (zh) * 2009-09-30 2012-05-30 孙泽 用于消毒、清洗血液透析机水路的消毒液及其制备方法
CN105579073B (zh) * 2013-09-27 2020-02-28 爱尔康公司 消毒和清洗隐形眼镜片的组合物和方法
CN115350306A (zh) * 2022-10-20 2022-11-18 北京安吉贝玛健康科技有限公司 可变浮力生成式氧气面罩消毒装置

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0367723A2 (fr) * 1988-11-04 1990-05-09 Ciba-Geigy Ag Méthode de production d'une solution stérile sans conservateur, pour aérosol
WO1993017721A1 (fr) * 1992-03-04 1993-09-16 Genencor International, Inc. NEUTRALISATION DE L'EAU OXYGENEE PAR LA CATALASE-R D'$i(ASPERGILLUS NIGER)
WO1995016017A1 (fr) * 1993-12-06 1995-06-15 Allergan Composition a base de sucre pour le nettoyage de lentilles de contact

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0367723A2 (fr) * 1988-11-04 1990-05-09 Ciba-Geigy Ag Méthode de production d'une solution stérile sans conservateur, pour aérosol
WO1993017721A1 (fr) * 1992-03-04 1993-09-16 Genencor International, Inc. NEUTRALISATION DE L'EAU OXYGENEE PAR LA CATALASE-R D'$i(ASPERGILLUS NIGER)
WO1995016017A1 (fr) * 1993-12-06 1995-06-15 Allergan Composition a base de sucre pour le nettoyage de lentilles de contact

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6241973B1 (en) * 1997-01-03 2001-06-05 Ari Rinne Method and product for cleaning and/or whitening of teeth
WO1998037921A3 (fr) * 1997-02-28 1998-12-17 Albert Sturm Produit d'entretien pour lentilles de contact
US6180393B1 (en) 1997-02-28 2001-01-30 Albert Sturm Water-soluble contact lens care product
US9427488B2 (en) 2009-06-29 2016-08-30 Menicon Co., Ltd. Disinfection system of contact lens
US10137218B2 (en) 2009-06-29 2018-11-27 Menicon Co., Ltd. Disinfection system of contact lens
US11331404B2 (en) 2009-06-29 2022-05-17 Menicon Co., Ltd. Disinfection system of contact lens
US12042567B2 (en) 2009-06-29 2024-07-23 Menicon Co., Ltd. Disinfection system of contact lens
WO2016085066A1 (fr) * 2014-11-28 2016-06-02 ㈜지엔케미컬 Composition d'enrobage de comprimés désinfectants et procédé de préparation de comprimés désinfectants enrobés par l'utilisation de celle-ci

Also Published As

Publication number Publication date
JPH11512834A (ja) 1999-11-02
CN1197397A (zh) 1998-10-28
EP0999857A1 (fr) 2000-05-17
AU698356B2 (en) 1998-10-29
AU7083696A (en) 1997-04-17
CA2231845A1 (fr) 1997-04-03

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