Preserve our Eyes, not our Drops!    Afficher en Français  Display in English

 

 

 

Intro

What's a Preservative

What are the Consequences

Who's at Risk

Are Labs Aware of This

Are Docs Aware of This

What Preservative Which Drop

Are There Alternatives

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Laboratories' awareness of the preservative issue

 

One has to recognise that not all laboratories are the same speech regarding preservative, however, all recognised to some extend that there is a problem related to preservatives. Some laboratories have completely eliminated preserved products from their brands of drops and gels. That is the case, for instance, of Théa and Horus-Pharma who committed themselves to the production of either single-use vials or unpreserved bottles.

Warning on preservatives by Thea

 

On the left, here's a warning on preservatives by Théa (English version), which one may find in the insert contained in the packages of their products. It states: "ABOUT PRESERVATIVES: Eye drops are a solution intended for instillation into the eye. This type of solution must be kept sterile in order to avoid the risk of microbial contamination of the eye. In order to ensure that sterility, most eye drops contain an antimicrobial agent known as a preservative. However, this type of product can cause allergic and/or toxic reactions on the surface of the eye and in the tear film; these conditions result in itching, burning sensation or watering of the eyes, and more generally in a feeling of discomfort. This intolerance is increased by prolonged use of the eye solution in question, which can occur with a long-term treatment for conditions such as dry eye [note from the editor, this sentence is sometimes replace by the following alternative ending: "such as allergic conjonctivitis". The ABAK® concept allows the instillation of eyedrops, preservative free."

 

Vision Pharma advises the following on their website: http://www.visionpharm.com/prodfeat.html

"NO preservatives.
Preservatives in eye drops are known to cause irritation and damage normal healthy tear constituents. The formulation and manufacturing process of VIVA-DROPS® achieves microbiological acceptance standards for ocular products without the need for a preservative."

Others have expressed more delicate shades of speech not to mention a contradictory one. The logic usually being that their preservative is less damaging than that of the competition (bellow you'll see an example from Allergan towards Alcon). These comparative studies are a way to acknowledge that there is a problem.

See bellow excerpts of explanatory brochures by Novartis regarding dry eyes in Norwegian. Let us remind you that dry eyes or lachrymal dysfunctions require the frequent long-term use of eye drops.

 Dry Eye Brocure Novartis Norway      Warning on preservatives by Novartis (NO)      Warning conditions that should avoid preservatives

Central page: « What do preservatives mean?  High consumption of eye drops with preservatives is not good for the eyes and long-term use may cause damage to the corneal cells. For that reason, you should choose products without preservatives whenever possible.»

Page on the right: “It’s especially important to choose tear substitutes without preservatives when you: use contact lenses, have sensitive eyes, are allergic to preservatives, use regularly other eyedrops with preservatives, high consumption of tears substitutes”.   

Bellow, a brochure by Novartis on allergic conjunctivitis in Norwegian. Reminder: Allergic conjunctivitis may require long-term treatments. 

Allergy Brochure by Novartis Norway     Advantages of unpreserved drops     Effects of preserved drops  

Central page: « Also without preservatives: Zaditen single vials do not contain preservatives. They are practical to carry and they are also suitable for contact lens uses – as drops do not (dis)colour the lenses. Anyhow, we advise you to always take out the contact lenses before putting the drops before putting them back on”.

Page on the right: “Long-term use of eyedrops with preservatives may cause damage to the cells of the cornea. Therefore, if possible, choose a product without preservatives”.

Bellow a brochure made for Allergan (New Zealand).

Allergan brochure New Zealand      Allergan Brochure from New Zealand

In the "How to relieve dry eye" section, “Single-use vials – These are preservative-free and are ideal for people who are sensitive to or concerned (SIC!) about preservatives, or who only require eye drops occasionally”. We find this advice rather curious since not using preservatives shouldn’t be motivated by the patients’ concerns as such but based on concerns as a result of studies demonstrating the consequences of preservatives. This actually shouldn’t the patients’ concern, but that of the laboratories which are supposed to do pharmacovigilance independent studies on this matter. The last sentence is also incorrect since it’s mainly frequent use (and not only occasional use) that certainly requires the use of single-use vials.

In the “A guide to lubricant eye drops" section: “Most multidose lubricant eye drops use two types of preservatives:

Detergent preservatives – such as benzalkonium chloride and Polyquad® may be toxic to the eye and damage the eye by breaking down cell membranes.

Oxidative preservatives – such as Purite® used in Allergan’s Refresh Tears  Plus® and Refresh Liquigel® lubricant eye drops, are kind on eyes and break down into the natural components of tears (water, oxygen and salts).

Purite® preservative is kind on eyes".

In the mild-to-moderate dry eye section,  the brochure advises two of Allergan’s products, which contain Purite® preservative, but also the preservative-free Refresh Plus® single vials that "are also suitable for use with contact lenses".

In the moderate-to-severe dry eye section, the brochure only advises one preserved product containing Purite® but 2 unpreserved products including “Lacrilube® preservative-free ointment [, which] is ideal for overnight treatment. Medecines have benefits and some have risks”

One can reach several conclusions: Allergan confirms the risks posed by preservatives, notably detergent ones (including the above-mentioned quaternary ammonium such as benzalkonium and Polyquad® which can be toxic and damaging to the eye). Allergan seems to confirm that contact lenses use combined with preservative use is an additional risk (for the lenses but also to the eye since lenses prolong retention time of the preservative at the surface of the eye).  

In Pfizer's Canadian website, a new unpreserved Visine is presented in its new formulation without benzalkonium thanks to an unpreserved container (as opposed to the majority of the Visine line unfortunately). The website mentions that "Preservatives contained in multi-dose bottled products have been shown to be sensitizing to some individuals". Actually, to consider the preservative problem as a sensitisation for some individuals problem means eluding part of the problem and notably the cytotoxic and tearfilm disruption effects of preservative. However, it's a first step towards the recognition that something must be done to ban benzalkonium from eye drops.

See http://www.pfizer.ca/english/our%20products/consumer...questions/eye%20care/default.asp?s=1
 

Some companies, Focus Laboratories and the Dry Eye Company, commercialise a new type of preservative (polexitonium) and claim its safety for dry eye drops. Focus Laboratories claims "FreshKote® has a unique preservative that is not only harmless to the eye but also makes the ocular surface more wettable, just the opposite of what some other preservatives do" in the following webpage http://www.freshkote.com/FAQ.asp. However, no clinical independent data supporting this claim has been provided. Other limited information we received on this preservative (cf, Consequences Per Preservative) mentions "very low toxicity", which cannot be deemed to support the harmless claim for long-term use let alone the increase wettability claim... in our opinion.

This is what we call the 'Preservative Paradox!

Preserve our Eyes, not our Drops!

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