The 100% preservative FREE laboratory

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What happens when we use preservatives?

Toward a preservative-free future

Leaders with the first preservative-free multidose vial, ABAK®, Laboratoires Théa are pioneering the development of preservative-free ophthalmic eyedrops that favour better ocular well-being for patients. The ABAK® vial allows treatment for up to six months after opening, guaranteeing maximum protection against contamination once the vial has been opened. Théa’s watchword: safety. Safety was made possible through the development over many years of preservative-free ophthalmic products for the eye surface.

The ABAK® system

The ABAK® bottle is a high-security, high-technology dispenser that delivers up to 300 drops through a filter that prevents microbial contamination. Continual improvements have made it smaller, more user-friendly, and more effective, and the contents can now be used for up to 6 months after opening as opposed to between 2 and 4 weeks for a classical preserved multi-dose bottle.

 

 

 

An eco-friendly innovation

This continually evolving concept constitutes real progress for the environment. A 10 ml ABAK® bottle contains 300 drops, enabling the contents to be administered 150 times in both eyes, in other words, the equivalent of 150 single dose units.

The innovative design of the tube is made of an airless pump, ensuring the protection of the gel from external contamination. It allows a preservative-free formulation composed only of essential ingredients. The airless pump technology provides an accurate and regular dosage of the gel, making application simple and easy.

Benefits of preservative-free

Given the abundance of preserved eyecare products on the market, you may surely wonder whether they perform better than non-preserved solutions. Studies have shown that preservative-free eyedrops have the same effectiveness as preserved ones.

In addition, the benefits of non-preserved eye drops include:

  • Better tolerance of the product
  • Better treatment compliance owing to better tolerance
  • Better surgical prognosis in the case of eye surgery, especially for glaucoma
  • Less inflammation on the eye surface and milder dry-eye syndrome
  • Preservative-free eyedrops are especially recommended in the case of chronic treatment (glaucoma, dry eye), and when the eye surface disorder is inflammatory (e.g. allergy).

Many studies have reported different symptoms between preserved and non-preserved eyedrops. In one study on 9,658 patients:

  • 42% of the patients felt a sensation of a foreign body on the instillation of preserved eyedrops.
  • 48% of the patients felt pain or discomfort during the instillation of preserved eyedrops.
  • Only 16% of the patients felt a sensation of eye dryness on instilling non-preserved eyedrops.

The European Pharmacopeia recommends that eye drops in multi-dose containers should contain an antimicrobial agent or preservative, to prevent and limit microbial contamination after opening.

However, studies have shown that preservatives are toxic to the ocular surface, especially for patients using eye drops over the long term.

There are different families of preservatives. They differ according to their physio-chemical properties, their spectrum of activity, and their toxicity and allergenic potency on the ocular surface. They include organomercury derivatives, amidines, alcohols, parabens and oxychloride complexes, as well as quaternary ammonium compounds, the main one of which, BAC, or benzalkonium chloride, is the most widely used preservative in ophthalmology.

The prolonged use of eye drops containing one or more preservatives leads to alteration in the tear film, in the superficial structures (conjunctiva, cornea), and the deeper parts of the eye (the lens, the trabecular meshwork).

The mildest ocular signs and symptoms show themselves as discomfort or irritation with a dry eye feeling. More severe secondary effects can be observed with variable levels of inflammation which can lead to the development of fibrosis in the eye, with an increased risk of failure in case of glaucoma surgery.

The severity of secondary effects depends on the duration of the treatment, the dosage and the type and concentration of the preservatives used in the eye drops.

The best way to limit these complications is to reduce the dosage frequency of preserved eye drops or ideally to use preservative-free eye drops.

Symptoms

The adverse effects first involve the conjunctiva and the cornea. In persons being treated with preserved eyedrops, 48% reported pain or discomfort on instillation (against 19% of persons treated with preservative-free eyedrops), 42% reported a sensation of a foreign body (against 15%) and 35% reported eye dryness (against 16% with no preservative).2

Quality of life and well-being can thus often be impacted by the harmful effects of preservatives on the eye surface.

Secondly, the preservatives affect the deeper structures of the eye such as the crystalline lens or the trabecular meshwork, and even deeper ones such as the retina.3

Patients being treated for glaucoma, for example, are especially concerned, because preservatives can cause inflammation.4 Glaucoma most often affects persons aged over 45 and is generally caused by an increase in the pressure inside the eye, which can damage the optic nerve. The most frequent treatment is the daily instillation of an ocular hypotensive agent. If it contains a preservative, there is a risk of red eyes and inflammation of the eye surface. In a study conducted in 2016, 95% of patients who had previously been using preserved eyedrops were satisfied or very satisfied with the tolerability of their new preservative-free treatment after 3 months of instillation.5

In some cases, surgery can be offered to patients with glaucoma to favour the elimination of aqueous humour. For such surgery to succeed, it is important to have a healthy conjunctiva. However, it can be inflamed through year-long use of preserved eyedrops This can jeopardize the surgery, which will accentuate the already existing inflammation. Fewer surgical complications have been observed in patients who were treated with preservative-free eyedrops.6 Chronic disorders such as dry eye syndrome can also occur with glaucoma, owing to the toxicity of the preservatives.

It is therefore preferable to avoid eyedrops containing preservatives, especially in the case of chronic treatment such as for glaucoma or dry eye syndrome (diminished quality and quantity of tears), or eye allergy; (e.g. allergic conjunctivitis), or if eye surgery is planned (cataract, glaucoma, refractive surgery, etc.).

If you wear contact lenses, preserved eyedrops can damage them. It is advisable to use preservative-free eyedrops. In addition, contact lens wearers tend to have a more fragile eye surface than the general population.7 They often use artificial tears to hydrate and lubricate their eye surface. They can thus greatly benefit from using preservative-free eyedrops.

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REFERENCES
1. Vaede D, Baudouin C, Warnet JM, Brignole-Baudouin F. [Preservatives in eye drops: toward awareness of their toxicity]. J Fr Ophtalmol. 2010 Sep;33(7):505-24.

2. Jaenen N, Baudouin C, Pouliquen P, Manni G, Figueiredo A,Zeyen T. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol 2007;17:341-49.

3. Messmer EM. Konservierungsmittel in der Ophthalmologie [Preservatives in ophthalmology]. Ophthalmologe. 2012;109(11):1064-1070.

4. Aptel F, Labbé A, Baudouin C, et al. Traitement du glaucome, conservateurs et surface oculaire [Glaucoma medications, preservatives and the ocular surface.]. J Fr Ophtalmol. 2014;37(9):728-736.

5. Muñoz-Negrete FJ. et al. Why risking the satisfaction and the compliance of your newly diagnosed glaucoma patient? The PASSY survey. Acta ophthalmologica. Volume 94, Issue S256, October 2016 – 14 Sept 2016, DOI: 10.1111/j.1755-3768.2016.0457

6. Boimer C, Birt CM. Preservative exposure and surgical outcomes in glaucoma patients: The PESO study. J Glaucoma 2013;22(9):730-5.

7. Pisella PJ, Malet F, Lejeune S, et al. Ocular surface changes induced by contact lens wear. Cornea. 2001;20(8):820-825.

8. Gomes JAP, Azar DT, Baudouin C, et al. TFOS DEWS II iatrogenic report. Ocul Surf. 2017;15(3):511-538.