Hylo-Vision SafeDrop Lipocur, 10 ml

Hylo-Vision, SafeDrop Gel Eye Drops
For intensive lubrication of dry eyes, even in cases of lipid deficiency. Relieves symptoms, regenerates, and rebuilds the tear film.

This product is a medical device. Please read the instructions in the package leaflet carefully and familiarize yourself with the functions and use before use.

Description:
Lubricating eye drops for moisturizing and protecting the surface of the eye with hyaluronic acid, lipids, and taurine. For intensive lubrication in all forms of dry eye, including those caused by lipid deficiency. Relieves symptoms, regenerates, and rebuilds the tear film. Natural protection through taurine. Sterile, phosphate-free solution without preservatives. Soothing, well-tolerated, and deeply penetrating. Suitable for hard and soft contact lenses.

What is Hylo-Vision SafeDrop Lipocur?
Hylo-Vision SafeDrop Lipocur is a sterile, phosphate-free wetting agent in the innovative SafeDrop system, a preservative-free, multi-dose container co-developed by OmniVision. Its practical, wide finger rest allows for optimal application.

Hylo-Vision SafeDrop Lipocur contains hyaluronic acid, glycerol, lipids, and taurine.

Hylo-Vision SafeDrop Lipocur supports all three layers of the tear film:
the aqueous layer (through the hyaluronic acid and glycerol), the lipid layer (through the lipids of castor oil), and the mucin layer (through the mucoadhesive properties of the hyaluronic acid).

Hyaluronic acid is a natural substance also found in the structures of the human eye and in the tear film, making it particularly well-tolerated. It is characterized by a high water-binding capacity and is viscoelastic. Furthermore, the hyaluronic acid adheres well to the ocular surface (mucoadhesive properties), thus increasing its dwell time. Glycerol is also a naturally occurring substance in the body and an additional moisturizing factor. Thanks to its moisture-retaining and moisturizing properties, glycerol, in addition to hyaluronic acid, stabilizes the aqueous layer of the tear film. Thus, Hylo-Vision SafeDrop Lipocur moisturizes, wets, and protects the surface of the eye, ensuring a uniform and stable moisture film on the cornea and conjunctiva.

The lipids (triglycerides) in castor oil supplement the lipid layer of the tear film, stabilize it, and reduce evaporation.

Taurine, another naturally occurring compound, is the most abundant amino acid found physiologically in the tear film and various tissues of the eye, such as the cornea, lens, retina, and vitreous humor. Taurine has osmoregulatory properties, is absorbed into cells, and penetrates deep into the eye. It supports the restoration of the osmotic balance, which is disrupted in dry eye, and protects the cells of the ocular surface from dehydration and oxidative stress.

In the treatment of dry eye, Hylo-Vision SafeDrop Lipocur thus provides lubrication, protection against evaporation, and osmoregulation thanks to its triple combination of moisturizing agents (hyaluronic acid and glycerol), lipids, and the body's own taurine.

It can be used for all forms of dry eye, both in cases of insufficient tear production (hyposecretory form) and excessive tear film evaporation due to lipid deficiency (hyperevaporative form). These eye drops are well-suited for dry, burning, and watery eyes (paradoxical dry eye). They provide moisture, improve the quality of the tear film, and protect the eye's surface.

Hylo-Vision SafeDrop Lipocur relieves symptoms, regenerates, and rebuilds the tear film. It offers natural protection through taurine.

Hylo-Vision SafeDrop Lipocur is well-suited for wetting hard and soft contact lenses, significantly improving wearing comfort.

Hylo-Vision SafeDrop Lipocur can be used for the following indications:

all forms of dry eye, e.g.:

• in cases of pronounced symptoms of dry eye and burning eyes
• in cases of watery eyes (»paradoxical dry eye«)
• Dry eyes due to lipid deficiency - meibomian gland dysfunction
• in cases of dry eyes, which are caused, for example, by Sjögren's syndrome or by taking medication.
• postoperatively, e.g. after cataract surgery, LASIK, LASEK
• in case of environmental stress, e.g. due to wind/drafts, cold, dryness, air-conditioned rooms or air pollution
• For fatigue and visual stress caused by intensive viewing, e.g., at computer screens, microscopes, or long car journeys.
• in the case of mechanical stress, e.g. by wearing hard or soft contact lenses or by diagnostic procedures on the eye.

When should you not use Hylo-Vision SafeDrop Lipocur?
If you have a known hypersensitivity (allergy) to any of the ingredients.

Who is Hylo-Vision SafeDrop Lipocur suitable for?

• Suitable for use with adolescents and adults.
• Pregnant women, breastfeeding women and children should consult their doctor before using Hylo-Vision SafeDrop Lipocur.

What side effects can occur when using Hylo-Vision SafeDrop Lipocur?

• After application, a temporary impairment of visual acuity (blurred vision) may occur. In this case, you should not drive or operate machinery. It is recommended to wait until normal visual acuity has returned.
• Immediately after instilling the drops, temporary symptoms such as a slight burning sensation in the eyes may occur.

What precautions and warnings should be observed?

• Do not use if the SafeDrop® multi-dose container is damaged.
• Do not touch the eye with the dropper tip to avoid infection or injury to the eye.
• The dropper tip must not touch other objects or body parts to avoid contamination of the product.
• Do not use as the sole treatment for an eye infection.
• Do not use the eye drops after the expiry date. This is printed on every SafeDrop bottle and the outer carton.
• For hygiene reasons, a single multi-dose container must not be used by multiple patients.
• Hylo-Vision SafeDrop Lipocur is not suitable as a storage solution for contact lenses.
• Hylo-Vision SafeDrop Lipocur should be kept out of the reach of children.
• If your symptoms persist during the use of Hylo-Vision SafeDrop Lipocur, please consult your ophthalmologist.

How is Hylo-Vision SafeDrop Lipocur used?

For external use only.

Step 1:
Before first use, please record the date the bottle was opened in the space provided on the bottle label. Wash your hands and remove the protective cap before each use.

Step 2:
Before first use, please press the SafeDrop® bottle several times until the first drop is dispensed. Hold the bottle upside down as shown in the illustration. Please avoid any contact between the dropper tip and your fingers or eye.

Step 3:
Hold the bottle as shown in the picture. Ensure your thumb rests on the wide, non-slip, round finger rest.

Step 4:
Now tilt your head back slightly (neck position) and gently pull down your lower eyelid with your free hand. Instill one or two drops of Hylo-Vision SafeDrop Lipocur into the conjunctival sac of each eye by pressing the pump mechanism once or twice. Ensure the bottle is held vertically. Close your eyes slowly so that Hylo-Vision SafeDrop Lipocur can spread evenly across the surface of your eyes.

Alternatively, if using the drops with contact lenses, apply one or two drops to each contact lens before inserting them into your eyes, instead of putting the drops directly into your eyes. Hylo-Vision SafeDrop Lipocur can also be used while wearing contact lenses.

After use, replace the protective cap on the multi-dose container.

How often and for how long should you use Hylo-Vision SafeDrop Lipocur?

Use Hylo-Vision SafeDrop Lipocur as needed or as directed by your ophthalmologist.

Hylo-Vision SafeDrop Lipocur is suitable for long-term use; however, as with any condition, you should consult an ophthalmologist if symptoms persist.

If you are also using other topical eye treatments, there should be an interval of approximately 30 minutes between applications. Hylo-Vision SafeDrop Lipocur should be applied after the other products.

The following pack sizes are available:
Eye drops in 10 ml and 2 x 10 ml SafeDrop multi-dose containers.

What storage and disposal instructions should be observed?
Store between 5°C and 25°C. Protect from frost and direct sunlight. Lot number and expiry date information can be found on the bottle and the outer carton. Once opened, Hylo-Vision SafeDrop Lipocur can be used for six months. Hylo-Vision SafeDrop Lipocur can be disposed of with household waste.

Composition:
Lipid phase (contains: glycerol, refined castor oil, tyloxapol, Tween 80, poloxamer 188, EDTA, vitamin E acetate, tromethamine HCl, tromethamine, purified water), taurine, sodium EDTA, tromethamine, sodium hyaluronate, HCl and NaOH (for pH adjustment), water for injection.

(Apo) Usually ship out within 3-5 business days