Thursday, May 29, 2008

Study: About that bad "office air"....

This one makes me think of those on DryEyeTalk who have reported ridiculously low humidity levels in their workplace and unsympathetic HR staff. It's good to have an increasing body of medical literature dedicated to how much the office environment affects even perfectly healthy eyes.

"Healthy" eye in office-like environments.
Wolkoff P.
Environ Int. 2008 May 20. [Epub ahead of print]

Eye irritation symptoms, e.g. dry eyes, are common and abundant symptoms reported in office-like environments, e.g. aircraft cabins. To improve the understanding of indoor related eye symptomatology, relevant knowledge from the ophthalmological and indoor environmental science literature has been merged. A number of environmental (relative humidity, temperature, draft), occupational (e.g. visual display unit work), and individual (e.g. gender, use of cosmetics, and medication) risk factors have been identified, which are associated with alteration of the precorneal tear film (PTF); these factors may subsequently exacerbate development of eye irritation symptoms by desiccation. Low relative humidity including reduced atmospheric pressure further increases the water evaporation from an altered PTF; in addition, work with visual display units may destabilize the PTF by lower eye blink frequency and larger ocular surface. Results from epidemiological and clinical studies support that relative humidity >40% is beneficial for the PTF. Only few pollutants reach high enough indoor concentrations to cause sensory irritation of the eyes, while an altered PTF may exacerbate their sensory effect. Sustained low relative humidity causes impairment of the PTF, while its stability, including work performance, is retained by low gaze and intermittent breaks.

Study: No comment.

Hmph.

I have a bad attitude about LASIK dry eye.
I have a bad attitude about Restasis, and
I have a bad attitude about the Journal of Refractive Surgery....

Therefore, I shall limit myself to simply pointing out the existence of this abstract (published in JRS about use of Restasis post LASIK), rather than subject you all to my perfect storm of attitude problems.

The effect of cyclosporine A (Restasis) on recovery of visual acuity following LASIK.
Ursea R, Purcell TL, Tan BU, Nalgirkar A, Lovaton ME, Ehrenhaus MR, Schanzlin DJ.
J Refract Surg. 2008 May;24(5):473-6.

PURPOSE: To compare the recovery of uncorrected visual acuity (UCVA) following LASIK in patients treated with topical cyclosporine A 0.05% and patients treated with a standard postoperative regimen.

METHODS: In this single-center, open-label, retrospective study, a standard refractive workup was performed in 45 patients (85 eyes) who underwent LASIK and did not have preexisting dry eye. In 36 eyes, a standard postoperative eye drop regimen was followed, and in 49 eyes, cyclosporine A 0.05% was added to the standard regimen for 12 weeks. Uncorrected visual acuity was measured 1 week and 1 and 3 months postoperatively.

RESULTS: One week postoperatively, 22 (44.9%) eyes in the cyclosporine A group and 8 (22.2%) eyes in the standard treatment group had UCVA of 20/15. Cumulatively, 36 (73.5%) eyes in the cyclosporine A group and 24 (66.7%) eyes in the standard treatment group had UCVA of 20/20 or better. One month postoperatively, 37 (75.5%) in the cyclosporine A group and 23 (63.9%) eyes in the standard treatment group had UCVA of 20/20 or better. Three months postoperatively, 40 (81.6%) eyes in the cyclosporine A group and 25 (69.4%) eyes in the standard treatment group had UCVA of 20/20 or better. Mean UCVA in the cyclosporine A group showed statistically significant improvements compared with the standard treatment group.

CONCLUSIONS: Cyclosporine A 0.05%, in the form of Restasis, may be an effective treatment for reducing the time needed for visual recovery after LASIK. Use of cyclosporine A was associated with overall better and faster recovery of UCVA.

Study: Acupuncture and dry eye

Good to see a new study on this. Wish the abstract said something about how long the effects lasted. If anybody has access to the journal and can look it up I'd sure be grateful if you'd let me know.

Treatment of intractable dry eyes: tear secretion increase and morphological changes of the lacrimal gland of rabbit after acupuncture.
Gong L, Sun X.
Acupunct Electrother Res. 2007;32(3-4):223-33.

Research on the effect of acupuncture for tear secretion and morphological changes of the lacrimal gland. Acupuncture therapy was given on the rabbits of New Zealand origin. The needles were inserted into the following acupoints around the right eye: Extra 1 (Taiyang), BL 2 ( Zanzhu) and SJ 23 (Sizhukong). The Schirmer Test I (S1T, The Schirmer test is probably the most commonly performed method of measuring aqueous tear production) values pre and post acupuncture therapy were blindly recorded. The lacrimal glands of the normal lacrimal gland group were stained by Hematoxylin and Eosin (HE) for light microscope examination and observed by transmission electron microscope. The S1T value was about sixty percent higher after acupuncture than before. Meanwhile changes also took place in the morphology of lacrimal gland tissu, indicated an active glandular function of synthesis and secretion. Acupuncture can increase lacrimal secretion by stimulating the rabbit lacrimal glandular function of synthesis and secretion.

Study: About those little PF vials...

Now, you all know how I feel about BAK laced glaucoma drops (and any other Rx drop that anyone is using on a regular basis). At the same time though, I have never believed that the answer could be as simple as making everything in preservative free unit doses instead - for several reasons, including cost and the physical challenge it poses to the elderly - who tend to be the greatest consumers of eyedrops because they have more chronic problems such as dry eye and glaucoma.

This study bears out the latter of those concerns: Only 57% of patients over 80 years old successfully administered drops from single use vials, compared with 89% of 80+ year olds using a bottle and 95% of 50-65 year-olds using PF vials. In my opinion, this underscores the need for less toxic preservatives than BAK and better, more practical preservative-free types of packaging.

Self-application of single-use eyedrop containers in an elderly population: comparisons with standard eyedrop bottle and with younger patients.
Dietlein TS, Jordan JF, L√ľke C, Schild A, Dinslage S, Krieglstein GK.
Acta Ophthalmol. 2008 May 20. [Epub ahead of print]

Purpose: To test whether patients aged >/=80 years can safely and successfully apply eyedrops from a single-use eyedrop container without support, and to compare the results with those of younger patients using single-use containers and older patients using standard eyedrop bottles.

Methods: Patients aged >/=80 years who had no physical or mental conditions hindering self-application of eyedrops and actually did so because of glaucoma or dry eyes were included consecutively in the study group (n = 44) in order to perform self-application of eyedrops from single-use eyedrop containers. Patients were observed meticulously by two investigators, who documented practical problems during the procedure in a checklist. In control group A (n = 22), glaucoma or sicca patients aged between 50 and 65 years applied drops from single-use eyedrop containers; in control group B (n = 28), glaucoma or sicca patients aged >/=80 years used a traditional eyedrop bottle.

Results: Successful application of the drops into the conjunctival sac was achieved by 57% in the study group (95% and 89% in control groups A and B, respectively). Scratching of the eyedrop container along the conjunctiva or cornea was observed in 68% of the study group (41% and 61% in control groups A and B, respectively). Frequency of problems during opening and self-application of single-use eyedrop containers in the study group showed an inverse correlation to visual acuity in the better eye and previous experience with this kind of eyedrop container.

Conclusion: Older patients have massive problems in self-administering eyedrops from single-use containers. Factors influencing the success of self-application may include the patient's previous experience with this kind of eyedrop container and the patient's visual acuity.

Wednesday, May 28, 2008

Musings about Dr. Holly's Drops and OTC vs Rx

Recently several people on Dry Eye Talk who have been suffering with severe dry eye for a long time have reported results ranging from new & good signs to major sustained improvement to near remission using Dr. Holly's Drops - primarily Dwelle & Dakrina, sometimes supplemented by NutraTear. This has been very exciting as well as gratifying.

It's been a long & hard road trying to keep those products alive in this tiny venture. Looking back over the years of DEZ I see so many mistakes (20/20 hindsight and all...). Of late I have often felt that I have not served the community well by being relatively reticent about the drops on DryEyeTalk in the past. I had a longstanding fear of being perceived as just using the board for marketing and so I probably went too far the other way to compensate. I also struggle with being unable to personally articulate the science of them very well (I'm in awe of people who not only understand but can explain...!)

You'd think that if the drops are all they're cracked up to be, there wouldn't be a need for anyone to talk them up in the forums. However..........

A major challenge with Dr. Holly's drops, in my opinion, is the mixed blessing of their over-the-counter status.

It's a blessing because it makes it possible to sell them at a relatively low price and since no prescription is required they are available to everybody.

However, OTC drops set people up with certain expectations (usually very low) as well as a completely different approach to trying them.

"Artificial tears" - as we refer to most OTC lubricant eye drops - are in general expected to give immediate and temporary relief at best and so that is how people use them - and judge them. So many, perhaps most people do not try any OTC drop for very long unless it has an immediate feelgood factor. And of course that is how the vast majority of the medical community view anything OTC.

But Dr. Holly's drops, or at any rate Dwelle and Dakrina (the two with the highest oncotic pressure) just don't lend themselves to that kind of "been there tried that didn't work" quick trial. They require diligent compliance. Sometimes they are actually uncomfortable, especially in the beginning. The overall experience can be more like an Rx drop.

Think how differently you feel about an Rx than an OTC. Whether or not it hurts, if you were "prescribed" it and instructed to use it twice a day, and especially if you dished out $50 just for the copay, you just keep using it for the period you were told to. People have completely different expectations and tolerances with Rx drops.

So in my view the OTC status of Dr. Holly's drops has held them back - both because of how consumers naturally view them, and because of how the vast majority of doctors view them. I learned this the hard way when I started the company and ran a large sampling program with hundreds of doctors. Although it was very educational for me (as a total newcomer to the industry), it was also a waste of time and money because so few doctors were willing to select patients carefully AND instruct them carefully. Most of them, no matter how hard you tried to impress on them how to use the drops, clearly just added the samples to their "tear sample" drawer from which they handed out whatever they had to any patient with dry eye of any kind.

There are exceptions to that of course. There are several corneal specialists as well as excellent optometrists around the country who treat Dwelle more like an Rx - they match the product to the patient deliberately, write it on a prescription pad, tell them where to buy it, and tell them exactly how many drops to use and when.

Not coincidentally, those are the doctors who get results.

One last comment....

Those of you on DryEyeTalk have undoubtedly seen many of Rojzen's comments about her experiences with Dwelle. This is probably the most exciting, inspiring and intriguing development I've come across in quite some time. Despite total meibomian gland atrophy and years of 24/7 dependency on moisture chamber glasses due to a zero tear break-up time, she's experienced a near complete turnaround of symptoms with patient, careful use of Dwelle - amazingly, just a couple of drops a day. Even though I've been a fan of these drops for so many years now, her experience has floored me and altered my understanding of the drops' potential. I'm still digesting the implications.

The classic way to look at dry eye is at the "three-layered tear film" level. Diseased lacrimal glands, can't make aqueous tears? Trap 'em, supplement 'em, maybe find a way to make more by reducing inflammation. Diseased meibomian glands, can't make oil? Heal and maintain the meibomian glands to make more and better meibum. Depleted goblet cells, can't make mucin? Scratch your head and pray for successful clinical trials of new drugs. And all these things are probably right and good. Problem is, as the DryEyeTalk forums are, at times, such a painful testimony to, there are a lot of people doing all of that and still not getting enough relief to make it through the day without a major, major hit to their quality of life.

Dr. Holly's drops think differently... not so much trying to alter or compensate for specific glandular conditions and misbehaviors but rather figuring out through the appropriate scientific channels the very best way to make and keep a surface as "wet" as possible even assuming chronically underperforming or irreparably damaged built-in moisture makers. (And who knows but whether having a healthier surface for longer may impact the lacrimal system itself somehow.)

If I've sorta-kinda got that right, I think it's at that level that many key scientific advances of the 1970s and 1980s were remarkable - but then came to a standstill and finally were almost completely shelved, ignored and all but forgotten by the medical community in the 90's and this decade where everything is all about trying to fight inflammation, usually from without, sometimes from within.

Interestingly, there are several signs of a renewed interest in Dr. Holly's work now.

I hope that spark can be fanned into a flame.