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Hydroxypropyl guar is a viscous protein polymer derived from beans. Upon instillation, hydroxypropyl guar forms a soft gel with increased viscosity at the tear pH. It mimics the properties of mucin layer by strengthening the attachment of the aqueous layer to the mucins and promotes the retention of other demulcents [ 20, 21]. It has also been shown to stabilize the tear film. Hydroxypropyl guar is present in all Systane ® brand artificial tears ( Table 3). Osmoprotectants are agents that protect cells against hyperosmolar stress-mediated injury. Since hyperosmolarity is one the characteristics of dry eye, osmoprotectants are emerging ingredients of artificial tears. Levocarnitine (L-carnitine) is present in prokaryotic and eukaryotic cells, including human corneal and conjunctival epithelia [ 11, 12]. Erythritol is polyol used as a low-calorie sweetener. In vitro studies using cultured human corneal epithelial cells demonstrate that osmoprotectants are taken up by the dehydrated cells, then restore volume and prevent protein denaturation [ 13, 14]. Trehalose is a naturally occurring disaccharide consisting of two alpha-glucose units joined by glucoside bond. Trehalose has also been shown to protect corneal epithelial cells from desiccation and high osmolarity [ 15, 16, 17]. Our data analysis demonstrated that erythritol, L-carnitine, and trehalose are present in some Refresh ® brand artificial tears, which contain CMC as the main demulcent ( Table 1). Refresh ® brand of artificial tears have several formulations containing 0.5% CMC alone, with additional demulcents and biologically active excipients like osmoprotectants erythritol, l-carnitine, and trehalose. L-carnitine and erythritol have been shown to attenuate hyperosmolar stress-mediated increase in MAP kinases, pro-inflammatory cytokines, and matrix metalloproteases in corneal epithelial cells [ 27, 28, 29, 30]. Clinical studies demonstrate that artificial tears containing L-carnitine and erythritol reduce tear osmolarity and provide symptomatic relief [ 31, 32, 33]. Studies in animal models of dry eye and clinical studies with trehalose containing eye drops demonstrate many beneficial effects, including increased tear production, tear stabilization, reduced corneal staining, and a decrease in corneal epithelial cell apoptosis [ 34, 35, 36, 37]. Humectant sodium hyaluronate in Refresh ®, Oasis ® and Blink ® tears can offer significant additional relief in dry eye in preventing or treating corneal epithelial damage since in vitro studies demonstrate that sodium hyaluronate promotes corneal epithelial cell migration and proliferation, thus facilitating healing [ 38, 39, 40]. Topical application of sodium hyaluronate in rabbits and mice has been shown to promote wound healing and relieve dry eye symptoms [ 41, 42]. Castor oils and flaxseed oil in some Refresh ® Brand tears will offer the additional benefit of reduced tear evaporation in patients with evaporative dry eye. Purite, the preservative present in Refresh ® brand artificial tears, is stabilized oxychloro complex (SOC) containing 99.5% chlorite, 0.5% chlorate. In solution, its bactericidal action is mediated by the oxidizing action of chlorine dioxide free radical. It belongs to the vanishing class of artificial tears since upon instillation, it is converted to sodium chloride, oxygen, and water [ 43, 44]. Animal studies demonstrate that purite is significantly less toxic to corneal epithelium compared to benzalkonium chloride but has some degree of detrimental effect compared to preservative-free artificial tears [ 43, 44, 45, 46, 47]. Given the wide variety of options, a patient can be started on Refresh ® tears with CMC alone either with or without preservatives depending upon the frequency of instillation required and if the dry eye relief is inadequate, Refresh ® tears with additional biologically active excipients can be tried. October 31, 2023 – Dublin, OH, Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.
One downside of the FDA’s pre-approved monograph is that if a developer lists an active ingredient that is not on the FDA monograph, they need to provide clinical data proving the safety of its ophthalmic use in humans. Many pharmaceutical excipients and food additives have been shown to provide therapeutic relief in dry eye disease. Although these excipients and additives have ophthalmic therapeutic potential, the manufacturers list them under inactive ingredients in artificial tears to avoid trials. Because of their notable biological activity, health care providers need to be aware of these excipients and additives. Therefore, we carefully reviewed the biologically active pharmaceutical excipients and food additives present in these drops. Brand names: Advanced Eye Relief Dry Eye, Alcon Tears, Artelac Nighttime, Artificial Tears, Bion Tears, If you are allergic to TheraTears Nighttime (carboxymethylcellulose); any part of TheraTears Nighttime (carboxymethylcellulose); or any other drugs, foods, or substances. Tell your doctor about the allergy and Tell your doctor right away if you have any serious side effects, including: eye pain, change in vision, continued eye redness/irritation. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medicalArtificial tears are available without a prescription. No single brand works best for every form of dry eyes. You may need to try several different brands before you find one that works best for you.
FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program: Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons Nov 13, 2023 | Audience: Consumers These products are available as over the counter (OTC) products used for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye, and/or to relieve redness of the eye due to minor eye irritations. Artificial tears contain one or more FDA-approved demulcents as active ingredient [ 8]. FDA defines demulcent as a primarily water-soluble polymer, which is applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation. The list of these demulcents and their concentration range was provided by the FDA in a 1988 monograph to help reduce the costs and expedite approval of artificial tears [ 8]. The FDA approved demulcents include (a) Cellulose derivatives: Carboxymethylcellulose (CMC), Hydroxypropyl methylcellulose (hypromellose), Hydroxyethylcellulose, Methylcellulose, (b) Dextran 70, (c) Gelatin, (d) Polyols: Glycerin, Polyethylene glycol (300, 400), Polysorbate 80, (e) polymers: Polyvinyl alcohol, Polyvinyl pyrrolidone (povidone).It is pertinent to be mindful of the over-the-counter eye drop recalls. Consult the FDA list of affected drops, or ask your eye care practitioner if your drops are safe to use if you’re unsure,” urges Melissa Barnett, OD, director of optometry at UC Davis in California. “An increased risk of infection and potentially vision loss may occur if contaminated drops are used.” Many times TheraTears Nighttime (carboxymethylcellulose) is used on an as needed basis. Do not use more often than told by the doctor. Some of these drugs need to be shaken before use. Be sure you know if this product needs to be shaken before using it.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/ tongue/throat), severe dizziness, trouble breathing. Brand names: Artificial Tears, Biolle Gel Tears, Biolle Tears, GenTeal, Lubricating Plus Eye Drops, Usually, drops may be used as often as needed. Ointments are usually used 1 to 2 times daily as needed. If using an ointment once a day, it may be best to use it at bedtime. All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medicalRefresh Celluvisc, Refresh Liquigel, Refresh Optive Advanced PF, Refresh Optive Advanced, Refresh Optive Mega-3, Refresh Optive PF, Refresh Optive, Refresh Plus, Refresh Relieva, Refresh Repair, Refresh Tears, Sterile Lubricant, TheraTears Nighttime, Theratears PF, Theratears, Ultra Fresh As well as helping your eyes to feel better, these drops can also make them look brighter and healthier. The product contains Euphrasia, also known as eyebright. This natural plant extract supports eye whitening. A lasting soothing effect If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using TheraTears Nighttime (carboxymethylcellulose)
doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Brimonidine Tartrate Ophthalmic Solution, 0.15%, NDC numbers 60505-0564-1, 60505-0564-2 and 60505-0564-3. Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections Oct 31, 2023 | Audience: Consumer, Health Professional, Ophthalmology, Pharmacy Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss of blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. The Harvard Drug Group, LLC has received three (3) reports of adverse events related to these products including reports of vision blurriness, vision loss, and burning eyes. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was As we age it is common to experience dry, tired, and irritated eyes due to the amount of tears our eyes produce naturally reducing. Changes in health conditions, certain medications and hormone balance during and after the menopause can also have an impact on eyes becoming more prone to drying out. Eye drops are intended to be sterile, especially due to a heightened risk for infection since they bypass some of the body's natural defenses by being applied directly into the eyes. As of this writing, Kilitch Healthcare India Limited “has not received any reports of adverse events related to this recall,” according to a news release posted by the FDA.
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