Question about Dwelle, Dakrina and Nutratear

[Toril]

I was wondering....how long can the drops be used after the bottle is opened? And how is it with the preservatives? It says here on dryeyezone that it's an non-irritating preservative....is there a survey behind that statement?

I get a bit comfused... some places you read that all preservatives is a no-no, and other places it's said that you should only be aware of the old, harsh ones.

Toril

[Dotanne]

Preservatives in drops

I have used Dwelle, Dakrina and Nutratears for over a month after I opened the bottles. No problems.
However I was given a new Allergan pamphlet(with some free samples) by the eye Dr and they had this comment on preservatives.
Detergent preservatives - such as benzalkonium chloride(BAK) and Polyquad may be toxic to the eye and damage the eye by breaking down cell membranes.
Oxidative preservatives - such as Purite* used in their products........ break down into the natural components of tears (water, oxygen and salts).

I presume the DEZ drops preservative is of the latter category?
We hear lots about BAK being not good but Polyquad? It would be interesting to know more?

Why do they keep putting BAK in the prescription drops such as steroids and my husband's Xalatan (for glaucoma)?
Dotanne

[kakinda]

HI,
I'm just trying the answer briefly according to what I know:
Whereas BAC harmfulness is well documented, polyquad a more recent preservatives is not... maybe that's why.
I received really bad reports from people using Polyquad too...
French docs seem really aware of this and in another thread you may see once again a study on BAC's toxicity...
Maybe Neil could elaborate on this... speaking from experience... I have had erosions caused by BAK.

Why do they keep putting BAK in the prescription drops such as steroids and your husband's Xalatan (for glaucoma)? and many other I might add...

Beats me! It doesn't make any sense knowing what I know about BAK!
Most of my docs deal with severe OSD, and have a hard time finding preservative free options for their patients... all chronic diseases taht require frequent use.

Either the industry doesn't care or maybe they're out of touch with clinical realities!!!!

More studies should be carried on the new preservatives and hopefully we won't have to wait for 15 years to learn that we have been damaging our eyes with harmful preservative... right Neil?
Take care
kakinda

[kakinda]

one more on glaucoma drops

Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication.

Pisella PJ, Pouliquen P, Baudouin C.

APHP Ambroise Pare Hospital, University Paris V, Ophthalmology Department, 9, avenue Charles de Gaulle, 92100 Boulogne, France.

AIM: To determine the incidence of ocular toxicity of preservatives with glaucoma medications. METHODS: A prospective epidemiological survey was carried out in 1999 by 249 ophthalmologists on 4107 patients. Ocular symptoms, conjunctiva, cornea, and eyelids were assessed. A chi(2) test was used for differences between preserved eye drops (P) and preservative free eye drops (PF). RESULTS: 84% patients used P, 13% received PF, and 3% a combination of P and PF eye drops. All symptoms were more prevalent with P than with PF drops (p<0.001): discomfort upon instillation (43% versus 17%), and symptoms between instillations such as burning-stinging (40% versus 22%), foreign body sensation (31% versus 14%), dry eye sensation (23% versus 14%), tearing (21% versus 14%), and eyelid itching (18% versus 10%). An increased incidence (>2 times) of ocular signs was seen with P eye drops. The prevalence of signs and symptoms was dose dependent, increasing with the number of P drops. A reduction in the symptoms and signs was observed when patients changed from P to PF eye drops (p<0.001). CONCLUSIONS: Symptoms and signs are less prevalent when PF drops are used. Moreover, most of the adverse reactions induced by P glaucoma medication are reversible after removing preservatives.

[kakinda]

one more on anti-allergic drops

[A comparative study of the ocular tolerance after administration of anti-allergic eye drops with or without a preservative]

[Article in French]

Beden C, Helleboid L, Marmouz F, Liard F.

Societe Naxis, Lyon, France. cecile.beden@naxis.fr

AIM: The aim of the study was to evaluate the occurrence of ocular adverse effects observed after administration of anti-allergic eye drops with and without a preservative in patients with allergic conjunctivitis. METHODS: A total of 3090 patients with allergic conjunctivitis and treated with anti-allergic eye drops were included in an open nonrandomised prospective study by 507 general practitioners located throughout France. The symptoms of discomfort and pain experienced during instillations as well as the characteristics of the patients and of their allergic pathology were recorded. RESULTS: Two groups of patients (eyedrops without preservative [n = 2712] and with preservative [n = 121]) were identified. Sixty percent and 15% of the cases of allergic conjunctivitis were associated with rhinitis and asthma, respectively, and for 70% of the occurrences, an identifiable factor (pollen, dusts, animals etc.) was responsible for the appearance of the symptoms. Compliance was significantly higher for anti-allergic eye drops without preservative than for those with a preservative (average number of instillations 3.5 vs 2.9/day, p < 0.001; number of instillations omitted 3.6 vs 4.2, p = 0.01). The proportion of patients experiencing at least one adverse drug reaction was 24% for eye drops with no preservative and 89% for eye drops with a preservative (p < 0.001). The most frequently notified symptom was a sensation of prickling and burning (10% and 47%, respectively, for eye drops with no preservative and eye drops with a preservative; p < 0.001). CONCLUSION: The prescription of eye drops with no preservative allows a significant decrease in ocular adverse drug reactions and a greater acceptance by the patient regarding his/her anti-allergic treatment.

[kakinda]

shall i continue

Comparison of the Short-Term Effects on the Human Corneal Surface of Topical Timolol Maleate With and Without Benzalkonium Chloride.

Original Articles
Journal of Glaucoma. 12(6):486-490, December 2003.
Ishibashi, Takeshi MD; Yokoi, Norihiko MD, PhD; Kinoshita, Shigeru MD, PhD

Abstract:
Purpose: To compare the short-term effects of timolol maleate with and without preservative (0.005% benzalkonium chloride) on pre-corneal tear film stability and corneal epithelial barrier function.

Subjects and Methods: The study population consisted of 20 healthy volunteers. To obtain baseline values, 7 days before the experiment the non-invasive breakup time of the pre-corneal tear film was measured using a tear specular microscope; corneal fluorescein uptake was measured with a fluorophotometer. Unpreserved or preserved 0.5% timolol was applied to one eye; the contralateral eye was exposed to the other drug. At 30 minutes after instillation, the pre-study tests were repeated.

Results: Preserved timolol did, while unpreserved timolol did not, significantly reduce the non-invasive breakup time from the baseline values (baseline and post-exposure values 11.4 and 6.8 seconds, respectively, P = 0.008 for preserved timolol, and 11.7 vs. 11.0 seconds, P = 0.55 for unpreserved timolol). Corneal fluorescein uptake, on the other hand, was significantly increased upon exposure to either preserved or unpreserved timolol (baseline and post-exposure values 37.5 and 82.0 ng/ml, P < 0.001 for preserved timolol, and 35.4 vs. 57.6 ng/ml, P < 0.001 for unpreserved timolol). Preserved timolol exerted the greater effect (P = 0.028).

Conclusions: Exposure to preserved timolol resulted in significant instability in the pre-corneal tear film. Moreover, it disrupted the corneal epithelial barrier function to a greater degree than unpreserved timolol. The elimination of preservatives may be desirable in efforts to protect the integrity of the corneal surface and its interaction with the tear film.

[kakinda]

Hi,

I'm so sorry Toril , I was so irrritated by this BAC (benzalkonium) issue and lack of interest by labs, and I'm clearly not the only one here, that I sort of occulted your important question to regarding Dwelle and Dakrina.

Although some new preservatives are less irritant, you can never exclude hypersensitivity to it or any other component in the drop for that matter...

I'd like to add one question myself: what preservative is it?

Take care
K

I was wondering....how long can the drops be used after the bottle is opened? And how is it with the preservatives? It says here on dryeyezone that it's an non-irritating preservative....is there a survey behind that statement?

I get a bit comfused... some places you read that all preservatives is a no-no, and other places it's said that you should only be aware of the old, harsh ones.

Toril

[Rebecca Petris]

Why do they keep putting BAK in the prescription drops such as steroids and my husband's Xalatan (for glaucoma)?

Because it is an effective as a preservative.

There was a study recently comparing it to other preservatives used in artificial tears in Europe. If I remember right none of the others in the study fully met all of their rigorous requirements for efficacy.

In all the frustration we all feel about preservatives that are harmful to those of us with ocular surface disease (dry eyes) - and harmful to many people who have healthy eyes - it's easy to lose sight of the fact that the first criterion for a preservative is to kill the bugs so that we don't have something worse befall our eyes than what the preservative itself may do to us. I hope that we will see more and more non-preserved unit doses become available as well as better, less irritating but still effective preservatives.

[Rebecca Petris]

I was wondering....how long can the drops be used after the bottle is opened?

I'm not sure there is any 'official' or authoritative answer to this. I think that if you're careful, I don't see why you can't keep it open till the expiry. I do personally. I prefer the small-size bottles and keep them everywhere... sometimes one will turn up that I haven't used in a long time (bottom of the purse...) and I've never had a problem with them. But you must be careful and ensure the tip never touches anything. When in doubt, about any topical eye product, toss it out.

And how is it with the preservatives?

Not quite sure what the question is? - There has never been an unpreserved version, so we've nothing to compare it to actually.

It says here on dryeyezone that it's an non-irritating preservative....is there a survey behind that statement?

In vivo cytotoxicity testing was done. The results indicated that frequent use of this preservative in a higher concentration than is in our products was no more irritating than plain saline.

Focus Laboratories, whose product Freshkote is very similar and contains the same preservative, state that it "facilitates the wetting of surfaces
Improves the ocular comfort and safety of patients wearing contact lenses", probably one of the reasons why the formulator, Frank Holly PhD, never made a non-preserved version.

I get a bit comfused... some places you read that all preservatives is a no-no, and other places it's said that you should only be aware of the old, harsh ones.

Opinions definitely vary within the medical community about the use of preservatives in over-the-counter tears. I spend a lot of time with doctors discussing their questions about our drops and I was actually surprised to find what a small percentage expressed any strong concern about it being preserved.

It's always a balancing act... you want the safest thing for your patient, and you want to keep it simple, so it's much easier to tell patients 'No preservatives' than say 'Only dissipating preservatives' or 'No BAK and no dissipating preservatives' or whatever (based on the doctor's actual opinion. On the other hand, most doctors are keenly aware that non-preserved tears are much more expensive than tears in a bottle, as well as more difficult to use. Overall compliance tends to be considered more important than the question of whether the preservative may pose some kind of elevated risks.

In my dealings with doctors I've found most very flexible about preservatives if they have full information available to them. The main exception I've run across is that they may require all preserved tears to be avoided for a certain period post-operatively.

[Rebecca Petris]

I'd like to add one question myself: what preservative is it?

Polexitonium, also called polyquaternium-42, also called Busan 1507. It's been in use in these 4 drops for many years. It's patent protected in the US and since these drops have never been marketed by a large pharmaceutical it's not at all well known.

[adamlau]

I am on a hunt for what works best for me and it looks as if I will have to give both Dakrina and Dwelle a shot....

[kakinda]

it's essential to have alternatives to BAC

Thanks for the info,
yes, it would be essential to have alternatives.... some people are unable to treat themselves because of the overwhelming use of BAC in drops and have developed an hypersensitivity.
This frequency in so many favours hypersensitivity and therefore intolerance.
Pharmas are therefore guilty of denying treatment to some people... twice!

And besides hyopersensitivity BAC is abrasive so what are they waiting for? beats me!!!

We do need PF and possibly less agressive preservative options for steroid dependent diseases, glaucoma, dry eye, allergy...
I hope that more studies will show that these options are an imperative need to be met very soon.

Take care
K