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    Nutritional supplement stimulates aqueous tear production

    Physicians confident in prescribing TheraTears Nutrition capsules for dry eye relief

    Woburn, MA-Advanced Vision Research has joined the growing number of physicians who have concluded that the anti-inflammatory properties of omega-3 fatty acids, such as those found in flaxseed oil, can relieve dry eye. The company recently added a dietary supplement containing these acids, TheraTears Nutrition, to its line of dry eye products.

    Dr. Donnenfeld
    TheraTears Nutrition softgel capsules contain flaxseed oil enriched with fish oil (containing eicosapentaenoic acid [EPA]) and several other substances that decrease inflammation, stimulate aqueous tear production, and augment the tear film oil layer by enhancing the flow of oil out of the meibomian glands, according to Jeffrey P. Gilbard, MD, founder and chief executive officer of Advanced Vision Research.

    Flaxseed oil is an important source of omega-3 essential fatty acids, one of two types that the body needs but can't produce. The other is omega-6, which is overabundant in the typical American diet. Much of that omega-6 is converted to arachidonic acid, which promotes inflammation.

    "Americans are eating way too much omega-6 fatty acid while being omega-3 starved," Dr. Gilbard said. "TheraTears Nutrition seeks to correct the imbalance that exists between omega-6 and omega-3 fatty acids and provide the patient with a convenient, safe, and effective way of doing that."

    Dr. Minardi
    Each daily dose also contains 200 IU of vitamin E to prevent oxidation and counter the depletion of serum vitamin E levels that occurs over time when people add significant amounts of omega-3 fatty acids to their diet, Dr. Gilbard said.

    "The fish oils in TheraTears are regulated by the Norwegian government and are molecularly distilled, so that they are free of heavy metals and PCBs, which makes them very safe," explained Dr. Gilbard.

    "Studies show that about 90% of Americans are deficient in omega-3 fatty acid intake," said Lawrence Minardi, MD, an oph- thalmologist in solo practice in Charleston, WV. "The omega-3 oils are really important for the meibomian glands to work properly. Since many of us are deficient in omega-3 oils, those meibomian glands develop a very thick secretion. Consequently, the oily layer of the tear film is deficient, and people who are deficient in omega-3 oils end up with an evaporative tear loss and dry eye syndrome."

    Dr. O'Brien
    Omega-3 fatty acids, found in salmon, tuna, herring, mackerel, and other cold-water fish, also affect dry eye through another mechanism, Dr. Minardi said. "These oils tend to be anti-inflammatory in the diet, and many cases of dry eye syndrome are related to inflammation of the lacrimal gland and the conjunctiva," he noted.

    "If we reduce the inflammation via the competitive inhibitory effect of omega-3 fatty acids on the arachidonic acid cascade, then there's less inflammation in the conjunctiva and in the lacrimal glands so there will be better tear production," Dr. Minardi added.

    Dr. Minardi also strongly recommends the reduction of simple carbohydrates in one's diet, such as bread (except for whole-grain breads), pasta, rice, and potatoes, which can adversely affect dry eye.

    "Flaxseed oil is so effective because it contains alpha-linolenic acid (ALA)," said Ernest W. Kornmehl, MD, FACS, Kornmehl Laser Eye Associates, Brookline, MA. "ALA is eventually converted to EPA, which is essentially fish oil. This, in turn, blocks the development of pro-inflammatory arachidonic acids and produces the anti-inflammatory eicosanoids prostaglandin E3 and leukotriene B5," he continued.

    TheraTears Nutrition also has a favorable effect on dry eye by stimulating tear production. PGE1 stimulates aqueous tear production by binding to E-prostanoid receptors EP2 and EP4 to activate adenylate cyclase and increase cyclic AMP, Dr. Gilbard said.

    Dr. Gilbard
    The addition of EPA also enhances the effectiveness of flaxseed oil by directly blocking the synthesis of tumor necrosis factor-alpha (TNF-alpha) and cyclooxygenase at the gene transcription level. Elevated tear film osmolarity causes increased TNF-alpha expression on the ocular surface, but EPA stops the synthesis of pro-inflammatory cytokines.

    Although TheraTears Nutrition is new on the market, the health benefits of flaxseed oil have been known for years and have been the subject of renewed interest from physicians who believe it might help patients with dry eye and a host of other medical conditions.

    Most recently, a study of 32,470 women participating in the Women's Health Study has found that women with a higher dietary intake of omega-3 fatty acids are at decreased risk of developing dry eye. The study, performed by a team of investigators from Harvard Medical School, was to be presented at the Association for Research in Vision and Ophthalmology annual meeting May 4-9 in Fort Lauderdale, FL.

    Dr. Minardi said that he has treated more than 300 patients with omega-3 fatty acid supplements, although not TheraTears Nutrition, in the last several years. "The overwhelming majority have seen significant improvement in their ocular symptoms and dry eyes," he said. "I have dry eye syndrome myself, and I've been taking it for 2 years. My dry eyes are immensely better."

    Dr. Minardi also suggests that patients take omega-3 fatty acid supplements before he performs LASIK, since most are omega-3 deficient. He recommends that they continue to use supplements afterward to avoid complications with dry eye that could negatively affect the results of the surgery. He also recommends the supplements to patients who wear contact lenses.

    Because TheraTears Nutrition contains flaxseed and fish oils as well as vitamin E, it is a simple way for patients to obtain relief from dry eye symptoms without having to buy different products that may be of variable quality, Dr. Kornmehl said.

    The appropriate amounts of each key ingredient also have been determined scientifically. "I'm very excited about this because it has those three components in one pill. Most doctors knew about flaxseed oil and fish oil and understood the science behind it but never knew how much to give each patient," he added. "Here, you can just take four capsules in the morning with your breakfast. I feel that it will be a very important part of our armamentarium in the treatment of dry eye meibomianitis and meibomian gland dysfunction."

    Anecdotal evidence suggests that patients who benefit most from TheraTears Nutrition are those who have dry eye in association with chronic meibomian gland dys- function, said Terrence P. O'Brien, MD, director, Ocular Infectious Diseases and Refractive Eye Surgery, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore. "I have noted a significant clinical improvement in the quality of the tear film enhancing stability and decreasing secondary evaporative loss of aqueous tears," Dr. O'Brien said.

    He added that more information is needed to determine which subsets of patients are most likely to benefit from using the supplement. "This is an exciting area, and one in which we need to conduct more studies to determine specific benefits to ocular and systemic health," he said.

    The effectiveness of TheraTears nutrition has surprised some physicians. "I'm not a big believer in nutritional supplements, and I was a little bit hesitant to believe that this was a product that was going to play a role in managing ocular surface disease and meibomianitis," said Eric Donnenfeld, MD, FACS, medical director, TLC Laser Eye Center, Garden City, NY. "I have really been taken aback by how effective it is in managing meibomian gland dysfunction and tear film instability."

    Corneal specialists often rely on antibiotics to manage meibomian gland dysfunction, but chronic use is required to maintain effectiveness, Dr. Donnenfeld said. TheraTears Nutrition offers an alternative, without the complications of long-term anti- biotic use, he added.

    Dr. Donnenfeld uses TheraTears Nutrition routinely for patients following LASIK and on patients who have signs of meibomian gland clogging. "They have markedly increased tear stability, and in addition they achieve significant increases in visual acuity," he said. "Patients who have ocular surface disease following LASIK will complain of visual fluctuation because their cornea breaks down. With the TheraTears Nutrition, we notice that their tear film is a lot more stable and they are able to see better, feel better, have less dryness, and have better visual acuity."

    The nutritional supplement should be used with artificial tears, preferably TheraTears, at least during the early phase of treatment, Dr. Gilbard said, since the supplement takes effect gradually over about 2 months.

    "The way to get rid of dry eye as soon as possible is to treat it from the inside as well as the outside," Dr. Gilbard said. "With the combination, patients get better faster, and some patients are able to stop their eyedrops."

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