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REGEFLUID THE TEAR FILM AND THE DRY EYE (1) The tear film Tears are produced by tiny glands surrounding the eye. The tear film is made of 3 layers: The lipid layer contains oils secreted by the meibomian glands, also called the tarsal glands. It forms the outer layer of the tear film which constitutes a hydrophobic barrier that prevents the evaporation of the aqueous phase and the spilling of tears down to the cheek. The aqueous layer contains water (99%) and other substances such as inorganic salts, glucose, urea and proteins secreted by the lacrimal gland and the nictitans gland. The aqueous layer is the thickest layer that plays a metabolic role: it supplies oxygen, water, glucose and electrolytes to the cornea and removes metabolites. The mucous layer contains mucins which are glycoproteins secreted by the conjunctival goblet cells. It is the inner layer of the tear film that coats the cornea. This layer serves as an anchor for the tear film and allow its adherence to the ocular surface by liaising a hydrophobic surface (cornea) to a hydrophilic surface (aqueous layer). Moreover, it protects the cornea, since it contains immunoglobulins A and lysozyme which slow down microbial progression. LIPID LAYER Triglycerides + Free fatty acids Anti-evaporation Tear film stability Water Glucose AQUEOUS LAYER Inorganic Salts Corneal nutrition and regeneration Proteins MUCOUS LAYER Immunoglobulin A + Lysozyme Mucins CORNEA The tear film plays many roles: • Keeps the eye moist • Nourishes the eye surface • Provides protection from injury (wind, dust, foreign body, etc.) • Provides protection from infection thanks to bacteriostatic substances that inhibit the growth of micro-organisms • Reduces surface friction associated with eyelid blinking and eye movement • Creates a smooth surface optimal for light passage through the eye Corneal protection Tear film adhesion REGEFLUID The Dry eye or Keratoconjunctivitis Sicca - DEFINITION Keratoconjunctivitis Sicca (dry eye) is a condition associated with conjunctival and corneal dryness. Any abnormality in one of the three tear layers produces tear film disorganisation, resulting in symptoms of Keratoconjunctivitis Sicca: Deficient tear production Keratoconjunctivitis Sicca is usually due to inadequate tear production. The lacrimal gland no longer produces a sufficient quantity of tears to cover the entire conjunctiva and cornea. Abnormal tear composition Keratoconjunctivitis Sicca can also be caused by abnormal tear composition resulting in rapid evaporation. Although the tear gland produces an adequate amount of tears, their evaporation rate is too rapid. The loss of water results in too "salty" or hypertonic tears. As a result, the conjunctiva and cornea are not fully protected by complete layers of tears. - AETIOLOGY • Hostile environment: wind, heat, dusts, etc. • Inflammation of meibomian glands or lacrimal glands. • Chalazion, also known as meibomian gland lipogranuloma, a cyst in the eyelid caused by inflammation of the meibomian gland. • Conjunctival inflammation causing destruction of conjunctival goblet cells. • Infections (Canine Distemper infection, Feline Herpes infection). • Injuries. • Neurological affection (Nerves VII or V). • Senility. • Removal of the third eyelid tear-producing gland (nictitans gland) during surgery for cherry eye. • Drugs such as antibiotics (Trimethoprim sulfa combinations), neuroleptics, antidepressants, atropine, etc. • Congenital alacrimia (small breeds’ size as Yorkshire) • Eyelid malocclusion or exophthalmia found in normal condition in brachycephalic dog breeds (Boston Terrier, Pekingese, Shih Tzu, etc.) • Immune mediated diseases with breed predisposition: American Cocker Spaniel, Miniature Schnauzer, West Highland White Terrier, Cavalier King Charles Spaniel, English Bulldog, Chinese Shar-Pei, Lhasa Apso, Shih Tzu, Pekingese, Boston Terrier, etc. - CLINICAL SIGNS Tear deprivation leads to ocular surface inflammation. This creates discomfort or pain associated with a sticky ocular discharge, corneal clouding and scarring, and eventually blindness if the process does not fall under control. The disease progression can be slow and insidious, and may affect one or both eyes. Different problems may be associated with dry eye: Chronic or recurring irritation or infection of the conjunctiva and/or cornea: conjunctivitis, keratitis or keratoconjunctivitis Corneal erosions or ulcers. Therefore, it is important to maintain a constant protection of the eyes. The quicker dryness is diagnosed, the better the prognosis. REGEFLUID REGEFLUID, ARTIFICIAL REGENERATING TEARS NATURAL TEARS-LIKE Regefluid is a new type of artificial tears. Artificial tears are lubricant eye drops used to reduce dryness and irritation associated with deficient tear production in Keratoconjunctivitis Sicca (dry eye). Artificial tears are combined with other treatments in moderate to severe forms of the disease. INGREDIENTS HYALURONIC ACID VITAMINS OL IGOELEMENTS BENEFITS • Mucoadhesive • Tear film adhesion • Visco-elastic • Protection and lubrification of the cornea (2, 3, 4, 5) • Residual action • Vitamin B12 • Vitamin PP (Nicotinamide) • M a g n e s iu m • M an g an ese • Natural nutritive components of the tear film • Nutrition of the cornea • Regeneration and repair of the cornea • Gly c in e AMINO-ACIDS PATENTED NUTRI-REGENERATING COMPLEX Glycosaminoglycan constitutive of the mucous layer of the tear film. PROPERTIES • Glu t a m ic a c id • Cysteine • Proline • Hydroxyproline POLYHEXAMIDE (PHMB) • Promote collagen synthesis • Antimicrobial • Regeneration and repair of the cornea • Microbiological growth reduction Hyaluronic acid is a natural substance found in the tears of dogs and cats. It helps to form and maintain the "pre-corneal tear film," a barrier that protects the eye from dehydration and damage resulting from exposure to the outer environment. This ingredient, in conjunction with a patented combination of nutrients essential and vital for the tear film (vitamins, trace elements, amino acids), create an ideal environment for corneal nutrition, lubrication and hydration. REGEFLUID THE PROOFS OF REGEFLUID NUTRITIVE ACTIVITY ON THE CORNEA (Study report n°EVE-ASPV-1, Laboratoire d’Investigation des Maladies de la Peau (LIMP), Marseille, October 2002) Culture of corneal epithelial cells Incubation at 37°C (Solution changed every day) AFTER 3 DAYS OF CULTURE IN REGEFLUID IN A STANDARD TEAR SUBSTITUTE ( BUFFERED SALINE SOLUTION WITH CA AND MG) Epithelial cells (6-7 layers) Basement ×550 PERFECT VIABILITY OF CORNEAL CELLS ×550 RAPID DEGENERATION OF CORNEAL CELLS REGEFLUID IS A REAL GROWTH MEDIUM FOR THE CORNEA Conclusions: Regefluid provides an excellent environment for corneal nutrition. Regefluid composition is similar to that of the natural tear film and thus meets corneal nutrition needs. As opposed to culture in the standard tear substitute, leading to rapid corneal degeneration, the Regefluid medium is optimal to maintain corneal integrity. REGEFLUID THE PROOFS OF REGEFLUID REGENERATING ACTIVITY ON THE CORNEA (Study report n°EVE-ASPV-3, Laboratoire d’Investigation des Maladies de la Peau (LIMP), Marseille, October 2002) CORNEAL EPITHELIUM LESION WITH THE TIP OF A SCALPEL Support ×275 ×275 REGEFLUID TRADITIONAL TEAR SUBSTITUTE Buffered saline solution with Calcium and Magnesium 3 times daily during 1 week at 37°C 3 times daily during 1 week at 37°C AFTER 7 DAYS OF TREATMENT ×275 ×275 COMPLETE REGENERATION INCOMPLETE REPAIR Continuous epithelium of 7-8 layers of cohesive and regular cells 3-4 layers of irregular and rounded cells. Presence of many vacuoles REGEFLUID PROMOTES CORNEAL REGENERATION Conclusions: Regefluid provides an excellent environment for corneal regeneration. The Patented Nutri-Regenerating complex contained in Regefluid promotes excellent corneal regeneration, notably thanks to its bio-mimetic composition very close to natural tears. REGEFLUID CONDITIONS FOR USE Regefluid may be used: To provide comfort to the eyes submitted to stress conditions - Brachycephalic breeds (Eyelid malocclusion or exophthalmia) - Dogs or cats exposed to drying conditions (heat, wing, dust) To support damaged cornea, in combination with the etiologic treatment - Irritative, infectious or chronic conjunctivitis (Regefluid + Soligental or Tiacil) - Viral keratitis (Regefluid + Soligental) - KCS in the early stage. For severe KCS, Humigel can be used in addition to Regefluid. - Corneal erosion (Regefluid + Soligental + VT Doses Atropine). In case of corneal ulcer replace Regefluid by VT Cic. DIRECTIONS FOR USE Apply 1 to 2 drops in both eyes 2 to 3 times daily. 1. 2. 3. 4. 5. CLERC B, (1997). Appareil lacrymal. In: Ophtalmologie Vétérinaire, 2ème Edition, Editions du Point Vétérinaire, 247-268. GOA KL, BENFIELD P, (1994). Hyaluronic acid. A review of its pharmacology and use as a surgical aid in ophthalmology, and its therapeutic potential in joint disease and wound healing. Drugs., 47, 3, 536-566. NAKAMURA M, HIKIDA M, NAKANO T, ITO S, HAMANO T, KINOSHITA S, (1993). Characterization of water retentive properties of hyaluronan. Cornea.,12, 5, 433-436. WEI G, DING PT, CUI YY, LI SM, ZHENG JM, (2002). Effect of solution viscosity on polymer precorneal residence time evaluated by in vitro method Yao Xue Xue Bao, 37, 6, 469-472. SNIBSON GR, GREAVES JL, SOPER ND, PRYDAL JI, WILSON CG, BRON AJ. (1990). Precorneal residence times of sodium hyaluronate solutions studied by quantitative gamma scintigraphy. Eye., 4, 4 , 594-602.