WA MALI MALTA USALTA 20170304193A1 AR DATATA TAMAN UTAMA ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017/ 0304193 A1 Soroudi (43 ) Pub . Date : Oct. 26 , 2017

(54 ) NON -IRRITATING , NON - BLURRING , A61K 31/ 4192 (2006 .01 ) PHOTOSTABLE OPHTHALMIC A610 17 /04 ( 2006 . 01 ) COMPOSITION A61K 3330 ( 2006 .01 ) ) U . S . CI. (71 ) Applicant: A . Ebbie Soroudi, Los Angeles , CA CPC ...... A61K 9/ 0048 (2013 .01 ) ; A61Q 17 /04 (US ) ( 2013 . 01 ) ; A61K 33 / 30 (2013 . 01 ) ; A61K 31 /215 (2013 .01 ) ; A61K 31/ 4192 ( 2013. 01 ) ; (72 ) Inventor: A . Ebbie Soroudi, Los Angeles , CA A61K 31/ 495 ( 2013. 01 ) (US ) (21 ) Appl . No . : 15 /648 , 107 (57 ) ABSTRACT A non - irritation , non - blurring, photostable ophthalmic sun ( 22 ) Filed : Jul. 12, 2017 screen composition contains at least one of the following : ; ; tris -biphenyl triazine ; and / or Related U .S . Application Data . A liquid vehicle base is then a (63 ) Continuation - in - part of application No. 14 /715 , 894 , remainder of the solution by weight. The composition is an filed on May 19 , 2015 . artificial tear formulation or an ophthalmic suspension or ointment. The composition may include at least one inor (60 ) Provisional application No. 62/ 000 , 071, filed on May ganic and /or at least one organic active ingredient . The 19, 2014 , provisional application No . 62 / 361, 189 , inorganic active ingredients may include , but not be limited filed on Jul . 12 , 2016 . to , , iron oxide , zirconium oxide , and cerium oxide . The organic active ingredients may Publication Classification include, but not be limited to , octinoxate , (51 ) Int. CI. octisalate , , , , para - amin A61K 9 / 00 ( 2006 .01 ) obenzoic acid , , methyl anthranilate , octocrylene , A61K 31/ 495 ( 2006 . 01 ) , , , trolamine salicylate , A6IK 31/ 215 ( 2006 .01 ) and . US 2017 /0304193 A1 Oct. 26 , 2017

NON - IRRITATING , NON - BLURRING , [0008 ]. Accordingly , protecting the ocular structures form PHOTOSTABLE OPHTHALMIC SUNSCREEN UV radiation may be beneficial in preventing such oxidative COMPOSITION damage that leads to all of these very common ophthalmic conditions . Until recently , the only proposed mechanism to CROSS -REFERENCE TO RELATED protect the eyes from UV radiation has been the use of APPLICATIONS glasses with UV protection , sunglasses, and tinted contact lenses . [0001 ] This continuation - in -part patent application claims [0009 ] There is a plethora of prior art suggesting the use priority to application Ser. No . 14 /715 ,894 filed on May 19 , of different physical and /or chemical sunscreen composi 2015 which itself claimed priority to provisional application tions for just the skin and formulations that won ' t damage 62/ 000 ,071 filed on May 19 , 2014 . This continuation - in -part the eye should any formulation get within the eye , but these application also claims priority to provisional application patents and prior art did not envision and / or describe the use 62 /361 , 189 filed on Jul. 12 , 2016 . The entire contents of all of such formulations for protecting the ocular structures in the priority applications (non - provisional and provisional ) any way . For example , Dueva -Koganov et al. ( Pub . No . : US are hereby incorporated in full by these references . 2010 /0226867 A1) proposed a " cosmetic and /or dermato logical” composition that are non - irritating to mammalian DESCRIPTION eyes. While this is a significant advantage for a dermato logical composition not to burn the eyes in case of inadver Field of the Invention tent contact, it does not describe the application of a solution [0002 ] The present invention generally relates to a sun that is designed for “ ophthalmic ” use per se. screen formulation designed for protecting the eyes includ [0010 ] There have been inventions that have proposed ing the conjunctiva , cornea , lens , and retina . More particu formulations specifically for the purpose of protecting the larly , the present invention relates to a non - irritating human eye from UV radiation , but such prior art has sunscreen that is applied directly onto the ocular surface of suggested formulations that are very different than what is the eye for protection from radiation . proposed herein with potential side- effects that may render them impractical for frequent use . Such prior art has pro Background of the Invention posed compositions that would make vision extremely blurry and / or be extremely irritating to the eyes, thus making [0003 ] Ultraviolet radiation is part of the electromagnetic them less suitable for frequent use by the general population . spectrum that reaches the earth from the sun . It has wave [0011 ] For example Michalos (U . S . Pat. No . 4 ,923 ,693 ) lengths shorter than visible light , making it invisible to the proposed the use of 0 . 3 - 0 . 4 % hydroxypropylmethylcellulose naked eye . These wavelengths are classified as UVA , UVB , in the form of an eyedrop or ointment applied to the eyes or UVC . UVA has the longest of the three at 320 -400 prior to exposure to UV radiation ) . This formulation , while nanometers . UVA is further divided into two wave ranges , effective against UV radiation , would affect vision tremen UVA I, which measures 340 -400 nanometers (nm , or bil dously and make it difficult for the user to see clearly for lionths of a meter ) , and UVA II which extends from 320 -340 hours . nanometers . UVB ranges from 290 to 320 nm . With even [ 0012 ] Baron ( U . S . Pat . No. 5 ,041 , 244 ) described an oph shorter rays , most UVC is fortunately absorbed by the ozone thalmic liquid sunglass that is composed of dosages of layer and does not reach the earth . chromophores in aqueous gel to block transmission of all or [0004 ] Both UVA and UVB penetrate the Earth ' s atmo various spectrums ofUV from the eyes . He has described the sphere and play an important role in conditions such as use of high molecular weight polymers which form viscous premature skin aging, eye damage , hair damage , and certain dispersions and can be used to prolong the curation of the skin cancers . chromophore when the gel is applied to the eye . This alone [0005 ] Photoconjunctivitis and Photokeratitis describe would cause significant blurring of the users ' vision . Further , conditions where ultraviolet radiation inflames and / or dam there is no mention of the irritation that' s caused once this ages the delicate structures of the ocular surface ( the con mixture is directly applied to the eye . This makes Baron ' s junctiva and the cornea , respectively ) . UV exposure to the invention not entirely practical for frequent use by the eyes ( either direct or indirect ) can cause severe redness , public . dryness , irritation , tearing , photosensitivity , and pain . This [0013 ] Smith ( U . S . Publication Number 2013/ 0331362 pain can be so severe as to cause chemosis and sloughing of A1) has described an Ophthalmic Solution For Absorbing the corneal epithelium with resultant scarring and even Ultraviolet Radiation and Method For Absorbing Ultraviolet permanent vision loss . Radiation , where he proposed two active organic ingredients [ 0006 ] Long - term ophthalmic exposure to UV radiation to protect the eyes from UVA and UVB radiation , respec has been associated with permanent thickening of the con tively . This formulation , while effective in theory , would junctiva ( called a pingueculum ) , vascular proliferation and cause significant irritation to the users ' eyes to the point that tissue growth over the cornea ( called a pterygium ), conjunc it would render the formulation unusable due to its severe tival discoloration (melanosis ), even cancer ( e . g . , conjunc side effects . These ingredients , used as described , would also tival/ uveal melanoma) . cause severe blurring of the users ' s vision due to the size of [0007 ] Long -standing UV exposure to the eyes has also the molecules proposed . This would also render the Smith been associated with damage to the internal structures of the formulation a poor candidate for regular use . Last, when it eyes , e . g . , the natural lens and the retina . Certain forms of comes to an ophthalmic preparation , the formulation must cataracts ( e . g . , nuclear sclerosis ) , as well as macular degen take into effect the fact that the ingredients used must be eration have been linked to the damage caused by oxidative photostable ( i. e ., that the UV filters don ' t break down or damage from UV exposure. degrade once exposed to UV light) . The Smith patent US 2017 /0304193 A1 Oct. 26 , 2017 proposes the use of avobenzone or octisalate , two of the homosalate, avobenzone , octocrylene , para - aminobenzoic most unstable sunscreen agents . This would further render acid , cinoxate , methyl anthranilate, octocrylene, padimate this formulation ineffective for its proposed use . O , ensulizole , sulisobenzone , trolamine salicylate and ecam [0014 ] From another standpoint, it is very important to sule . consider how to dissolve or disperse the proposed ingredi [0021 ] The first portion may comprise 0 . 25 percent to 10 ents in a mixture , which could be utilized as an eye drop / percent by weight. The first portion may comprise 0 . 25 suspension /ointment . The Smith patent publication has not percent to 5 percent by weight. The liquid vehicle base may described a method with which the proposed ingredients be water -based or oil- based . could be mixed into a vehicle that could be utilized for 10022 ] Other embodiments may include an emulsifier . The ophthalmic use . The present invention fulfills needs for a emulsifier may be selected from the group consisting of a new form of UV radiation ophthalmic protection and pro silicone - based emulsifier, a polyethylene glycol emulsifier, a vides other related advantages addressing all of the chal polysiloxane emulsifier, a glyscoside emulsifier , an acrylic lenges aforementioned . based emulsifier and combinations thereof. The emulsifier 100151 This present disclosure describes the composition may comprise polysorbate , carbomer and / or castor oil . of a sunscreen solution , suspension , emulsion , and / or an [0023 ] Other embodiments may include an emollient. The ointment that is designed to be directly applied to the eye emollient may be selected from the group consisting of aloe itself to protect it from UV damage without causing signifi extracts , oleaginous esters , ethers and combinations thereof. cant irritation to the eye or affecting the users ' vision . The The emollient may comprises an anhydrous lanolin and / or present invention fulfills these needs for a new form of UV an oleaginous ingredient. radiation protection and provides other related advantages . [0024 ] Other embodiments may include a preservative , wherein the preservative is an ionic - buffered preservative, a SUMMARY OF THE INVENTION detergent or an oxidizing detergent. [ 0016 ] Advances in our understanding of the sun protec [ 0025 ] Other embodiments may include a chelating agent tive effects of organic and inorganic ingredients has lead to or an antioxidant. the development of sunscreen preparations with very effec [ 0026 ] The ophthalmic sunscreen solution may be in the tive protection against the ultraviolet rays of the sun . Until form of an eye drop , a suspension , an emulsion , or an now , the effects of these ingredients has only been described ointment, all of which are synthesized specifically to be for the skin , and the prior art has warned against the use of applied onto the ocular surface . such ingredients on the ocular surface . In fact, people are 100271 Other embodiments may include an ophthalmic asked to rinse their eyes thoroughly in case such ingredients demulcent , wherein the ophthalmic demulcent is a cellulose get into their eyes. The present invention describes the specific use of such ingredients onto the ocular surface itself. derivative demulcent or a liquid polyol. The present invention proposes formulations that provide [0028 ] Other embodiments may include a hypertonicity very high SPF for the eyes, while causing minimal irritation agent , wherein the hypertonicity agent is sodium chloride. without making vision blurry . [ 0029 ] Other embodiments may include an ophthalmic [ 0017 Examples of embodiments of the present invention lubricant or an ophthalmic astringent. include compositions that are manufactured as ophthalmic (0030 ) The first portion may be in micronized or nano solutions, emollients , creams, or ointments that can be particle form . instilled directly on the eyes . It is understood that the use of [0031 ] Another embodiment of the present invention the term " ophthalmic solution ” shall include emollients , includes an ophthalmic solution comprised of diluted forms creams and ointments that can be instilled directly on the of an inorganic active ingredient such as titanium dioxide, eyes. zinc oxide , iron oxide , zirconium oxide, cerium oxide , or [ 0018 ] An embodiment of the present invention of an mixtures thereof. This composition may also contain a weak ophthalmic sunscreen solution , comprises: a first portion concentration of an organic active ingredient such as comprising 0 .25 percent to 15 percent by weight, wherein avobenzone , octinoxate , octisalate , homosalate , octocrylene , the first portion comprises at least one of the following: para -aminobenzoic acid , cinoxate , dioxybenzone , methyl bemotrizinol; bisoctrizole ; tris -biphenyl triazine ; and /or anthranilate , octocrylene , padimate O , ensulizole , sulisoben octylmethoxycinnamate ; and a second portion comprising a zone , trolamine salicylate , ecamsule , and mixtures thereof. liquid vehicle base comprising a remainder of the solution [0032 ]. An example embodiment of the present invention by weight. includes an ophthalmic sunscreen composition which is [0019 ] Other embodiments may include a third portion comprised of anywhere from 0 .25 % to up to 15 % zinc oxide comprising an inorganic active ingredient comprising 0 .25 by weight. percent to 15 percent by weight. The inorganic active [0033 ] Another example of this invention includes ingredient may be selected from the group consisting of embodiments comprised of octinoxate and / or octisalate . titanium dioxide , zinc oxide, iron oxide, zirconium oxide , [ 0034 ] Another example of this invention includes cerium oxide and mixtures thereof and wherein the inor embodiments comprised of an emulsifier , silicone - or ganic active ingredient is in micronized form or nanoparticle acrylic -based , glycosides , polyethylene glycols , or a mixture form . thereof. 10020 ) Other embodiments may include a third portion [ 0035 ] Another example of this invention includes comprising an organic active ingredient comprising 0 . 25 embodiments comprised of sunscreen composition compris percent to 15 percent by weight and wherein the organic ing an emulsifier selected from the group consisting of active ingredient is in micronized form or nanoparticle form . Arlacel P 135 , DC 9011 silicone elastomer, Abil WE 09 , Abil The organic active ingredient may be selected from the EM - 90 , Emulgade 68 / 50 , Simulgel A , Simulgel EG , and group consisting of dioxybenzone, octinoxate , octisalate , mixtures thereof. US 2017 /0304193 A1 Oct. 26 , 2017

[0036 ] Another example of this invention includes Example 1 embodiments comprised of an emollient. Said emollient may be selected from the group consisting of Aloe extracts, [0048 ] An ophthalmic sunscreen solution can be synthe ethers , oleaginous esters , and mixtures thereof . sized by mixing 5 % micronized zinc oxide and 3 % octinox [0037 ] Another example of this invention includes ate in an ophthalmic artificial tear formulation . This solution embodiments comprised of an emollient selected from the may contain carboxymethylcellulose sodium 0 . 1 % ; glycerin group consisting of actiphyte of aloe vera, Cetiol OE , Lexol 0 . 25 % ; boric acid ; calcium chloride dihydrate ; erythritol; IPL , octyl palmitate , neopentyl glycolheptanoate , neopentyl levocarnitine; magnesium chloride hexahydrate ; potassium glycol diheptanoate, Trivent NP - 13 , CJ2 — is alkyl benzoate , chloride ; purified water ; sodium borate decahydrate ; and and mixtures thereof. sodium citrate dihydrate . [0038 ] Other features and advantages of the present inven tion will become apparent from the following more detailed Example 2 description , when taken in conjunction with the accompa 00491. An ophthalmic sunscreen solution can be synthe nying drawings, which illustrate , by way of example , the sized by mixing a range of 5 % micronized titanium dioxide principles of the invention . and 3 % octisalate in an ophthalmic artificial tear solution . DETAILED DESCRIPTION OF THE Example 3 PREFERRED EMBODIMENTS [0050 ] An ophthalmic sunscreen ointment can be synthe [0039 ] Examples of ophthalmic sunscreen compositions sized by mixing a range of 5 % micronized zinc oxide and of the present invention provide an SPF of up to 50 or higher. 3 % octinoxate in an ophthalmic ointment consisting of As the eyes are usually not in direct exposure to UV hypromellose , boric acid , sodium perborate , phosphonic radiation as opposed to the skin , such high SPF ratings may acid , potassium chloride, purified water, and sodium chlo not be necessary for the present invention , and as such , the ride. concentration of the active ( and inactive ) ingredients may be [ 0051 ] The present disclosure describes the composition much lower than those proposed for dermal use . of an ophthalmic sunscreen utilizing Tinosorb® (preferably [0040 ] The application of much lower concentrations of Tinosorb M , IUPAC name 2 ,2 '- methanediylbis [6 -( 2H -ben these ingredients will lead to much lower incidences of zotriazol- 2 - yl) - 4 - ( 2 , 4 , 4 -trimethylpentan - 2 - yl) phenol] ) as its ophthalmic irritation / stinging when applied , and will lessen active ingredient. Tinosorb® is the trade name of a number the known side - effects of such ingredients . Further, by of UV absorbers including the following : bemotrizinol ( Ti reducing the concentrations of these ingredients , possible nosorb® S ) ; bisoctrizole ( Tinosorb® M ) ; tris- biphenyl tri absorption of these ingredients into the eye ( i . e . , through the azine ( Tinosorb® A2B ); and octyl methoxycinnamate ( Ti Cornea ) will be reduced as to prevent possible intra -ocular nosorb® OMC) . Tinosorb® M is a photostable sunscreen effects ( e . g ., cataract formation ) . composition that possesses multiple chemical characteristics 10041] Compositions of the present invention are now over all other sunscreen agents currently available , that described , but are not limited to these embodiments . render it as an ideal candidate for use in a sunscreen 10042 ] Ophthalmic sunscreen compositions according to formulation that is designed specifically to be directly the present invention may contain a liquid vehicle base , such applied to the ocular surface . as an artificial tear formulation , which may be water and / or [0052 ] Bisoctrizole (marketed by BASF as Tinosorb® M oil -based , or an ophthalmic suspension or ointment and and by MPI as Milestab 360 , INCImethylene bis -benzotri include at least one inorganic and at least one organic active azolyl tetramethylbutylphenol) is a benzotriazole -based ingredient. organic compound that is added to to absorb UV [0043 ] Inorganic active ingredients may include, but not rays . Bisoctrizole is a broad -spectrum ultraviolet radiation be limited to zinc oxide , titanium dioxide, iron oxide , absorber, absorbing UVB as well as UVA rays , which makes zirconium oxide , and cerium oxide , optionally in micronized it an ideal active ingredient for an ophthalmic sunscreen form as to prevent blurred vision when applied . composition . It also reflects and scatters UV adding to its [0044 ] Organic active ingredients may include , but not be SPF capability for this specific application . Bisoctrizole is a limited to dioxybenzone , octinoxate , octisalate , homosalate , hybrid UV absorber, the only organic UV filter produced and avobenzone , octocrylene, para -aminobenzoic acid , cinoxate , microfine organic particles ( < 200 nm ) , like microfine zinc methyl anthranilate , octocrylene , padimate O , ensulizole , oxide and titanium dioxide. Where other organic UV absorb sulisobenzone , trolamine salicylate , and ecamsule . ers need to be dissolved in either the oil or water phase , [0045 ] The inactive ingredients of the present invention bisoctrizole dissolves poorly in both . Bisoctrizole is added shall also include emulsifier ( s ) and / or emollient( s ). Silicone to the water phase of a sunscreen as a 50 % suspension , based emulsifiers like polyethylene glycols , polysiloxanes, whereas mineral micropigments are usually added to the oil glycosides are excellent choices. Acrylic -based emulsifiers, phase . The bisoctrizole particles are stabilized by the sur and mixtures thereofmay also be used safely for the present factant decyl glucoside. This allows for an ideal ophthalmic preparation . Emollients may include , but not be limited to preparation that could be used in suspension form . aloe extracts , oleaginous esters , and ethers, or a combination [0053 ] Bisoctrizole shows very little photodegradation thereof. and has a stabilizing effect on other UV absorbers, octyl [0046 ] The composition of the present invention shall also methoxycinnamate ( octinoxate ) in particular . This is an include , but not be limited to preservatives , chelating agents , extremely important factor when considering the very low and / or antioxidants . concentration of the active ingredient that can be used in a [0047 ] The following examples describe a composition of formulation that is to be applied directly on the ocular the present invention , but it is obviously not intended to limit surface . When formulated into a dermatologic sunscreen , the scope of the invention . bisoctrizole has minimal skin penetration . Work is still in US 2017 /0304193 A1 Oct. 26 , 2017 progress by our laboratory to study its penetration into the which is comprised of Tinosorb® with an organic , as well as Conjunctival or Corneal Tissues, but as an Ophthalmic an inorganic sunscreen an artificial tear Sunscreens, it should impregnate the surface layers of the [0062 ] vehicle . Conjunctiva & Cornea so that its not washed outby blinking [0063 ] Another example of this invention includes said or the natural tears constantly irrigating the ocular surface . solution containing embodiments comprised of an emulsi Bisoctrizole may penetrate the Conjunctiva and build a fier , silicone - or acrylic -based , glycosides , polyethylene concentration in the episcleral connective tissue , and per - glycols , or a mixture thereof. meate through the Cornea and build an effective concentra [0064 ] Another example of this invention includes tion in the eye ' s anterior chamber (aqueous humour) and embodiments comprised of sunscreen composition compris serve as an effective barrier for UVA & UVB light that enters ing an emulsifier selected from the group consisting of the eye , potentially preventing cataract formation and /or Arlacel P 135 , DC 9011 silicone elastomer , Abil WE 09 , Abil macular degeneration . EM - 90 , Emulgade 68/ 50 , Simulgel A , Simulgel EG , and [ 00541 Unlike some other organic sunscreen actives , mixtures thereof. Tinosorb® has shown no estrogenic effects in vitro . [0065 ] Another example of this invention includes Although there is very little systemic absorption of such embodiments comprised of an emollient. Said emollient agents when used on the ocular surface , it is a positive may be selected from the group consisting of Aloe extracts , finding that this agent is safe in this regard . Tinosorb® one ethers , oleaginous esters , and mixtures thereof. of the first UV filters that have been made available in [0066 ] Another example of this invention includes micronized " nano ” form , and used in this format, it will embodiments comprised of an emollient selected from the minimize significant irritation to the eye or affecting the group consisting of actiphyte of aloe vera , Cetiol OE , Lexol users ' vision . Further, Tinosorb® used in Particulate form IPL , octyl palmitate , neopentyl glycol heptanoate , neopentyl ( smaller than 100 nanometers ) causes significantly less /no glycol diheptanoate , Trivent NP - 13 , CJ2 — is alkyl benzoate , blurring for the user . From a preparation standpoint, Nano and mixtures thereof. particle easily dispersible in oil or glycol systems, making it [0067 ] Compositions of the present invention are now an ideal preparation for an ophthalmic emulsion . described , but are not limited to these embodiments . [ 0055 ] Advances in our understanding of the sun protec [0068 ] Ophthalmic sunscreen compositions according to tive effects of organic and inorganic ingredients has lead to the present invention may contain a liquid vehicle base , such the development of sunscreen preparations with very effec as an artificial tear formulation , which may be water and /or tive protection against the ultraviolet rays of the sun . Until oil - based , or an ophthalmic suspension or ointment and now , the effects of these ingredients has only been described include at least one form of Tinosorb® ( e . g ., Tinosorb® M ) for the skin , and the prior art has warned against the use of by itself , or mixed with an organic - and / or an inorganic such ingredients directly on the ocular surface . In fact , molecule with UV protecting features . Tinosorb® can be people are asked to rinse their eyes thoroughly in case such used in nano form , and refers to a number of UV absorbers : ingredients get into their eyes. The present invention Bemotrizinol ( Tinosorb® S ) , Bisoctrizole ( Tinosorb® M ) , describes the specific use of such ingredients , particularly Tris - Biphenyl Triazine ( Tinosorb® A2B ), Octyl methoxy Tinosorb® , onto the ocular surface itself . The present inven cinnamate ( Tinosorb® OMC ). tion proposes formulations that provide UV protection for [ 0069 ] Inorganic active ingredients may include, but not the eyes, while causing minimal irritation without making be limited to zinc oxide , titanium dioxide , iron oxide , vision blurry . zirconium oxide , and cerium oxide , optionally in micronized [0056 ] Examples of embodiments of the present invention form as to prevent blurred vision when applied . include compositions that are manufactured as ophthalmic [ 0070 ] Organic active ingredients may include, but not be solutions , emollients , creams, or ointments that can be limited to dioxybenzone , octinoxate, octisalate , homosalate , instilled directly on the eyes . It is understood that the use of avobenzone , octocrylene , para -aminobenzoic acid , cinoxate , the term " ophthalmic solution ” shall include emollients , methyl anthranilate , octocrylene , padimate O , ensulizole , creams and ointments that can be instilled directly on the sulisobenzone , trolamine salicylate , and ecamsule . eyes . 10071 ] The inactive ingredients of the present invention [ 0057 ] An embodiment of the present invention includes shall also include emulsifier( s ) and / or emollient( s ) . Silicone an ophthalmic solution comprised of diluted forms of based emulsifiers like polyethylene glycols , polysiloxanes , Tinosorb® an inorganic active ingredient by itself, or mixed glycosides are excellent choices. with a weak concentration of another organic active ingre [0072 ] Acrylic - based emulsifiers , and mixtures thereof dient. may also be used safely for the present preparation . Emol [ 0058 ] An example embodiment of the present invention lients may include, but not be limited to aloe extracts , includes an ophthalmic sunscreen composition , which is oleaginous esters , and ethers , or a combination thereof. comprised of Tinosorb® in an artificial tear vehicle. 10073 ]. The composition of the present invention shall also [0059 ] Another example embodiment of the present include , but notbe limited to preservatives , chelating agents , invention includes an ophthalmic sunscreen composition , and /or antioxidants . which is comprised of Tinosorb® with an organic sunscreen [0074 ] The following examples describe a composition of ( e . g . , Avobenzone ) in an artificial tear vehicle . the present invention , but it is obviously not intended to limit 10060 ] Another example embodiment of the present the scope of the invention invention includes an ophthalmic sunscreen composition , [0075 ] Example 1 : An ophthalmic sunscreen solution can which is comprised of Tinosorb® with an inorganic sun be synthesized by mixing 5 % micronized Tinosorb® Min an screen ( e . g ., Zinc Oxide ) in an artificial tear vehicle . ophthalmic artificial tear formulation . This solution may 10061] Another example embodiment of the present contain carboxymethylcellulose sodium 0 . 1 % ; glycerin invention includes an ophthalmic sunscreen compositionon , 0 .25 % ; boric acid ; calcium chloride dihydrate ; erythritol; US 2017 /0304193 A1 Oct. 26 , 2017 levocarnitine ; magnesium chloride hexahydrate ; potassium 11. The solution of claim 9 , wherein the emulsifier com chloride ; purified water, sodium borate decahydrate ; and prises polysorbate , carbomer and / or castor oil . sodium citrate dihydrate . 12 . The solution of claim 1 , including an emollient . [0076 ] Example 2 : An ophthalmic sunscreen solution can 13 . The solution of claim 12 , wherein the emollient is be synthesized by mixing a range of 5 % Tinosorb® with selected from the group consisting of aloe extracts , oleagi micronized titanium dioxide and 3 % octisalate in an oph nous esters , ethers and combinations thereof. thalmic artificial tear solution . This solution may contain 14 . The solution of claim 12 , wherein the emollient is carboxymethylcellulose sodium 0 . 1 % ; glycerin 0 .25 % ; comprises an anhydrous lanolin and/ or an oleaginous ingre boric acid ; calcium chloride dihydrate ; erythritol; levocar dient . nitine; magnesium chloride hexahydrate ; potassium chlo 15 . The solution of claim 1 , including a preservative . ride ; purified water ; sodium borate decahydrate ; and sodium 16 . The solution of claim 15 , wherein the preservative is citrate dihydrate . an ionic -buffered preservative , a detergent or an oxidizing [ 0077 ] Example 3 : An ophthalmic sunscreen ointment can detergent. be synthesized by mixing 5 % micronized Tinosorb® Min an 17. The solution of claim 1, including a chelating agent. ophthalmic ointment consisting ofhypromellose , boric acid , 18 . The solution of claim 1 , including an antioxidant. sodium perborate , phosphonic acid , potassium chloride , 19 . The solution of claim 1 , wherein the ophthalmic purified water, and sodium chloride . sunscreen solution is in the form of an eye drop , a suspen [0078 ] Although several embodiments have been sion , an emulsion , or an ointment, all of which are synthe described in detail for purposes of illustration , various sized specifically to be applied onto the ocular surface . modifications may be made to each without departing from 20 . The solution of claim 1 , including an ophthalmic the scope and spirit of the invention . Accordingly , the demulcent . invention is not to be limited , except as by the appended 21 . The solution of claim 20 , wherein the ophthalmic claims. demulcent is a cellulose derivative demulcent or a liquid What is claimed is : polyol. 1 . An ophthalmic sunscreen solution , comprising : 22. The solution of claim 1 , including a hypertonicity a first portion comprising 0 .25 percent to 15 percent by agent. weight , wherein the first portion comprises at least one 23 . The solution of claim 1, wherein the hypertonicity of the following: agent is sodium chloride . bemotrizinol; 24 . The solution of claim 1 , including an ophthalmic bisoctrizole ; lubricant. tris -biphenyl triazine; and /or octylmethoxycinnamate ; 25. The solution of claim 1 , including an ophthalmic a second portion comprising a liquid vehicle base com astringent. prising a remainder of the solution by weight. 26 . The solution of claim 1 , wherein the first portion is in 2 . The solution of claim 1, including a third portion micronized or nanoparticle form . comprising an inorganic active ingredient comprising 0 .25 27 . An ophthalmic sunscreen solution , comprising : percent to 15 percent by weight. a first portion comprising 0 .25 percent to 15 percent by 3 . The solution of claim 2 , wherein the inorganic active weight, wherein the first portion is in micronized form ingredient is selected from the group consisting of titanium or nanoparticle form , and wherein the first portion dioxide , zinc oxide , iron oxide , zirconium oxide , cerium comprises at least one of the following : oxide and mixtures thereof and wherein the inorganic active bemotrizinol; ingredient is in micronized form or nanoparticle form . bisoctrizole ; 4 . The solution of claim 3 , including a third portion tris -biphenyl triazine; and /or comprising an organic active ingredient comprising 0 .25 octyl methoxycinnamate ; percent to 15 percent by weight and wherein the organic a second portion comprising an inorganic active ingredi active ingredient is in micronized form or nanoparticle form . ent comprising 0 .25 percent to 15 percent by weight, 5 . The solution of claim 4 , wherein the organic active wherein the inorganic active ingredient is selected from ingredient is selected from the group consisting of dioxy the group consisting of titanium dioxide, zinc oxide , benzone , octinoxate , octisalate , homosalate , avobenzone , iron oxide , zirconium oxide , cerium oxide and mixtures octocrylene , para- aminobenzoic acid , cinoxate , methyl thereof , wherein the inorganic active ingredient is in anthranilate , octocrylene , padimate O , ensulizole , sulisoben micronized form or nanoparticle form ; zone , trolamine salicylate and ecamsule. a third portion comprising an organic active ingredient 6 . The solution of claim 5 , wherein the first portion comprising 0 . 25 percent to 15 percent by weight, comprises 0 . 25 percent to 10 percent by weight. wherein the organic active ingredient is selected from 7 . The solution of claim 5 , wherein the first portion the group consisting of dioxybenzone , octinoxate , octi comprises 0 .25 percent to 5 percent by weight. salate , homosalate , avobenzone , octocrylene , para 8 . The solution of claim 5 , wherein the liquid vehicle base aminobenzoic acid , cinoxate , methyl anthranilate , is water -based or oil- based . octocrylene , padimate O , ensulizole , sulisobenzone , 9 . The solution of claim 1 , including an emulsifier. trolamine salicylate and ecamsule ; and 10 . The solution of claim 9 , wherein the emulsifier is a fourth portion comprising a liquid vehicle base com selected from the group consisting of a silicone -based emul prising a remainder of the solution by weight , wherein sifier, a polyethylene glycol emulsifier , a polysiloxane emul the liquid vehicle base is water -based or oil- based ; sifier, a glyscoside emulsifier , an acrylic - based emulsifier wherein the ophthalmic sunscreen solution is in the form and combinations thereof. of an eye drop , a suspension , an emulsion , or an US 2017 /0304193 A1 Oct . 26 , 2017

ointment, all of which are synthesized specifically to be thereof, wherein the inorganic active ingredient is in applied onto the ocular surface . micronized form or nanoparticle form ; 28 . An ophthalmic sunscreen solution , consisting essen a third portion comprising an organic active ingredient tially of: comprising 0 . 25 percent to 15 percent by weight, wherein the organic active ingredient is selected from a first portion comprising 0 . 25 percent to 15 percent by the group consisting of dioxybenzone , octinoxate , octi weight , wherein the first portion is in micronized form salate , homosalate , avobenzone , octocrylene , para or nanoparticle form , and wherein the first portion aminobenzoic acid , cinoxate , methyl anthranilate , consists essentially of: octocrylene , padimate O , ensulizole , sulisobenzone, bemotrizinol; trolamine salicylate and ecamsule ; and bisoctrizole ; a fourth portion comprising a liquid vehicle base com tris -biphenyl triazine ; and /or prising a remainder of the solution by weight, wherein octyl methoxycinnamate ; the liquid vehicle base is water- based or oil -based ; a second portion comprising an inorganic active ingredi wherein the ophthalmic sunscreen solution is in the form ent comprising 0 .25 percent to 15 percent by weight, of an eye drop , a suspension , an emulsion , or an wherein the inorganic active ingredient is selected from ointment, all ofwhich are synthesized specifically to be the group consisting of titanium dioxide , zinc oxide , applied onto the ocular surface . iron oxide , zirconium oxide , cerium oxide and mixtures * * * * *