Friday, October 26, 2007

Study: Improving contact lens tolerance on dry eyes

Well, I confess I have rather mixed feelings about this one.

On the one hand it's all very sensible and really raises some excellent points. For example, it stresses that choice of contact lens solutions may be just as important as choice of lenses. Reminds me, my sister recently found that Lobob for soft contacts dramatically improved her lens performance.

On the other hand, when read by laypeople I would worry that the details of a study like this get glossed over and instead people take it as encouragement to stubbornly persist in contact lens wear without sufficiently investigating and dealing with the ocular surface problems.

But anyway, I appreciate what appears to be quite a thorough discussion of how to improve contact lens prospects for people with mild dry eye.

Contact lens strategies for the patient with dry eye.
The Ocular Surface, 2007 Oct;5(4):294-307.

ABSTRACT Dry eye is the most common reason for contact lens (CL) discontinuation, and the patient with pre-existing dry eye presents particular challenges to the CL fitter. Poor tear film quality/stability, oxygen deprivation, lens deposits, and adverse reactions to CL solutions all contribute to dry eye, and lid disease, allergies, environmental factors, and medications can further hamper successful CL wear by the patient with dry eye. Health and comfort of the ocular surface is affected by the water content, ionicity, oxygen permeability, and modulus of elasticity of the lens, as well as by surface characteristics, such as protein, lipid, and mucin deposition; protein adsorption; and wettability. The choice of CL cleaning solutions with regard to action, cytotoxicity, and biocompatibility are as important as the choice of the CL itself. With appropriate management of the lid, meibomian gland, and ocular surface conditions that produce dry eye, careful selection of lenses and solutions, and vigilant follow-up, successful CL wear should be achievable for the dry eye patient.

Study: Dry eye, MEGS, and computer users

At last - somebody's actually published something about moisture chambers!!

Even if it is just a plug for a product just about to be commercialized. Even if they did choose a product name that screams GEEEEEK. It's still better than nothing. I've been pushing moisture chambers ever since I acquired my first pair of Panoptx. The benefits can be remarkable and in my opinion there needs to be a concerted effort to dispel the perception that they are a tool only for the end-stage incurable dry eye patient. From the manufacturers, we need products that don't look like the dreaded "dry eye goggles".

So here's the scoop. MEGS (Micro-Environment Glasses). Sigh, this poor product is screaming for marketing help, starting with the name, but never mind that for the moment.

Isolation of the ocular surface to treat dysfunctional tear syndrome associated with computer use.

Yee RW et al, The Ocular Surface 2007 Oct;5(4):308-15.

ABSTRACT Dysfunctional tear syndrome (DTS) associated with computer use is characterized by mild irritation, itching, redness, and intermittent tearing after extended staring. It frequently involves foreign body or sandy sensation, blurring of vision, and fatigue, worsening especially at the end of the day. We undertook a study to determine the effectiveness of periocular isolation using microenvironment glasses (MEGStrade mark) alone and in combination with artificial tears in alleviating the symptoms and signs of dry eye related to computer use. At the same time, we evaluated the relative ability of a battery of clinical tests for dry eye to distinguish dry eyes from normal eyes in heavy computer users. Forty adult subjects who used computers 3 hours or more per day were divided into dry eye sufferers and controls based on their scores on the Ocular Surface Disease Index (OSDI). Baseline scores were recorded and ocular surface assessments were made. On four subsequent visits, the subjects played a computer game for 30 minutes in a controlled environment, during which one of four treatment conditions were applied, in random order, to each subject: 1) no treatment, 2) artificial tears, 3) MEGStrade mark, and 4) artificial tears combined with MEGStrade mark. Immediately after each session, subjects were tested on: a subjective comfort questionnaire, tear breakup time (TBUT), fluorescein staining, lissamine green staining, and conjunctival injection. In this study, a significant correlation was found between cumulative lifetime computer use and ocular surface disorder, as measured by the standardized OSDI index. The experimental and control subjects were significantly different (P < 0.05) in the meibomian gland assessment and TBUT; they were consistently different in fluorescein and lissamine green staining, but with P > 0.05. Isolation of the ocular surface alone produced significant improvements in comfort scores and TBUT and a consistent trend of improvement in fluorescein staining and lissamine green staining. Isolation plus tears produced a significant improvement in lissamine green staining. The subjective comfort inventory and the tbut test were most effective in distinguishing between the treatments used. Computer users with ocular surface complaints should have a detailed ocular surface examination and, if symptomatic, they can be effectively treated with isolation of the ocular surface, artificial tears therapy, and effective environmental manipulations.

New drug news: Alcon / Lantibio and HLA

Once a dry eye drug gets to a certain point in clinicals it's only a matter of time till you hear a big ophthalmic pharma's name connected with it. And considering Alcon's meager dry eye offerings, I'm even less surprised to see that they jumped at the chance to market Lantibio's drug (currently in phase III clinicals) in the US.

Hyaluronic acid drops of various sorts are available as over-the-counter lubricants around the world but not in the US because HLA is not included in the FDA's monograph for ophthalmic demulcents (that little-known and poorly understood way the FDA has of regulating over-the-counter eye lubricants). Probably no one living remembers the last time anyone tried to change that monograph and these days, no one would be motivated to try, because selling drops on a prescription basis is a far more shareholder-friendly idea.

I never actually saw a news release on Alcon's deal with Lantibio and TRB... just saw it buried in their third quarter results announced a few days ago.

New drug news: Re-inspired.

You've got to hand it to them for persistence. Prolacria is not going away, at least not yet.

Inspire tries again with dry eye drug

The News & Observer, Oct 20 2007

Inspire Pharmaceuticals hired a Massachusetts company to test its troubled dry-eye drug, Prolacria.

The medicine has been in regulatory limbo since it failed the second of four clinical trials two years ago.

Prolacria has been tested on 2,000 patients with mixed results. After talks with the Food and Drug Administration, Inspire said in a regulatory filing that it will test the effectiveness of the drug in a particular part of the eye.

Inspire has agreed to pay Ophthalmic Research Associates of North Andover, Mass., up to $34.5 million if the test results get Prolacria regulatory approval.

News & controversy: Patenting damaged rabbits for use in dry eye research?

(Sorry, I'm a couple months late on this one.)

Now I've heard everything. I don't even think I can trust myself to comment on this, so I'll just provide links and quotes.


Can an animal be patented?


Here's a link to the patent application.

Newsblurb: Canine dry eye

Just for a change of pace, I thought I'd post about a veterinary Q&A on canine dry eye that caught my eye. Kind of eye-opening, because doctors are apparently rather more blunt about prognosis and treatments when they're talking about your pooch than about you:

Dog's eye requires lubrication
(Detroit News, Oct 13 2007)

The problem with KCS in younger dogs is that it is more likely to be a case of abnormal or lack of development of the lacrimal gland. Clinical signs may vary considerably between dogs, but typically include ocular discharge, a dull-appearing corneal surface, red eye and failure to open the eye. Corneal changes may include ulceration, vascularization, pigmentation and scarring...
...You will most likely be treating this condition for the rest of the dog's life.

News: Ulster Herald on dry eye

If we think dry eye news coverage is inadequate in the US... well, we're actually doing pretty well compared to many other places. I was very pleased on behalf of our Dry Eye Talk friends in northern Ireland to see this piece:


Not a dry eye in the house

(sigh, every journalist seems to think that is clever)

It's rather, er, barebones, but hey, any coverage is better than no coverage.


Dry eye syndrome is an extremely common condition in which symptoms can range from subtle irritation to inflammation of the tissues of the eyes.

Tears are essential for good eye health since they wash out dust and debris, keep the eye moist and neutralise bacteria that colonise the eye.

DRY EYE SYNDROME

In dry eye syndrome, the eye doesn't produce enough tears, or they evaporate off the eye surface too quickly.

The resulting effect can be a gritty, burning or itchy sensation. Occasionally, people complain of excessive watering of the eyes when the tissues try to overcompensate for the lack of moisture.

CAUSES

There are many causes of dry eye syndrome. Many medications, such as antihistamines or oral contraceptives , can cause dry eyes as a side effect, as can general health complaints such as rheumatoid arthritis and rosacea.

Eyes become dry as a natural part of the ageing process, especially during the menopause.

Symptoms can be exacerbated by environments such as central heating, air conditioning , or using the computer for a long period of time.

TREATMENT

Dry eyes per se cannot be cured, but the symptoms can be managed. Artificial tears can be used to lubricate the ocular surface, while air humidifiers can add moisture to air that's been heated or conditioned. Silicone plugs can be used to block lacrimal (tear) ducts and retain your natural tears on your eye.

Essential fatty acids can reduce dry eye problems, cold water fish, and flax seed oil may also be beneficial.

If contact lenses are the cause of dry eyes, your contact lens practitioner may switch you to a different lens material.

If you are considering LASIK , dry eyes may disqualify you for the surgery.

New drug news: Civamide in Phase III and acquired by OPKO

Wow, a new one slipped in right under the radar. Well, the more the merrier.

OPKO Health Acquires Rights to Clinical Stage Compound for Dry Eye (October 10, 2007)

The compound, civamide, a proprietary TRPV-1 receptor modulator and neuronal calcium channel blocker, is in Phase III clinical trials in an intranasal formulation to treat various types of pain. Increased tear production was observed in over 50% of the patients receiving civamide, and no systemic side effects were noted. Preliminary evidence suggests that civamide's effects on tear production result from its ability to modify signal transduction pathways present in the human lacrimal gland.


At first blush I kind of wonder how dry eye patients will feel about putting an arthritis treatment up their nose, but then, there's a lot of desperation in the dry eye crowd. If it works, well, I'm sure they'll have a market.

Corporate news: QLT/Forsight Newco acquisition & that new punctal plug technology

This is not directly related to dry eye but this emerging technology about a punctal plug drug delivery system is kind of intriguing (as well as worrying, frankly). Stay tuned on this one.

QLT hits 52-low on eye deal - October 9, 2007

As the first clinical candidate utilizing this cutting edge platform technology, it will target glaucoma, by replacing eye drops, dry eye, allergies and postoperative care. The company expects the products to represent a $6 billion market.

News (not): "New look for LASIK surgery"

I can hardly believe newspapers are still cranking out this kind of thing. Musta been an awfully slow news day in Colorado.

...a 30-year-old outdoor enthusiast in Boulder, long wanted to undergo laser eye surgery so he could ditch the glasses he's worn since the fifth grade.

But it wasn't until recently that laser eye technology became good enough to correct Schaffer's severe astigmatism, a vision problem caused by an irregularly shaped cornea...
During the 10-minute outpatient procedure, Schaffer's surgeon... used a new technology called the IntraLase laser to create a flap in the surface tissue covering each of Schaffer's corneas. Then he used an excimer laser to correct the shape of the corneas, which play a crucial role in reflecting light onto the eyes' retinas.

(Rocky Mountain News, Oct. 2, 2007)

SNORT. New technology? Come on folks. Intralase launched their fourth generation machine in 2006. Femtosecond technology is not new. It's just that it's taken many surgeons till now to amortize their excimers enough to afford one.

But, ahem, forgive my digression from dry eye. Here's what really caught my eye:

Understand the risks: Laser eye surgery provides good results for the vast majority of patients, but complications such as severe dry eye, halos, glare, double vision and vision that worsens at night can occur. The probability of serious long-term complications is less than 0.5 percent.


These sorts of combination statements really bother me because while each individual statement might be defensible or explainable, the overall impression conveyed is false. A normal ignorant consumer would read this and have no way of knowing that "serious long-term complications" does NOT refer to the complications named in the previous sentence - which, according to years of medical studies, clearly have a considerablyl greater than 0.5% rate of occurrence.... My point being that a normal consumer would read this and conclude that they have an 0.5% or less chance of getting severe dry eye.

Sorry, but that's just plain wrong. Read the literature. Heck, read even a standard consent form.

Study: Contamination of ophthalmic solutions (hmm... have we got a solution for you)

Ran across an Ocular Surgery News report on a British Journal of Ophthalmology study (October issue) which found a pretty frightening 8% of eyedrops - particularly steroids, but also including a couple of drops for dry eyes, presumably OTC lubricants - that were in use at a long-term-care facility were contaminated.

One of the comments of the authors:

The frequent contamination during reuse of certain steroid-containing ophthalmic solutions raises the question of whether single-use solutions might be preferred for these and other classes of ocular drugs


Hey, any study that will help encourage development of unpreserved unit doses of any and all prescription eyedrops is welcome around here. Keep it up boys & girls.

Thursday, October 18, 2007

New drug news: ALTY-0501 update

According to a recent press release (PDF), Alacrity Biosciences' ALTY-0501 has had some positive results in its Phase II study.

ALTY-0501 is basically a very low dose topical doxycycline aimed at "preventing the disruption of the epithelial barrier on the ocular surface".

Study design sounded kind of interesting:

The Phase 2 study utilized the controlled adverse environment (CAE) chamber to measure dry eye patients' ability to withstand a stressful drying environment on the eye, and patient diaries to measure the severity of their dry eye symptoms over the course of the study. Patients were randomized to receive ALTY-0501 or its vehicle four times each day over the course of a 56 day study.


Like all dry eye testing they seek to demonstrate improvement in both signs and symptoms. In this case, "signs" were exclusively staining (numbers for total, superior and nasal were reported), and "symptoms" of burning, stinging and grittiness were somehow gleaned from patient diaries (sure would like to know how that was structured!).

Alacrity are hoping to move forward with Phase III clinicals in early 2008.

Wednesday, October 17, 2007

Eyewear news: Wiley-X, Panoptx & more

Oh my goodness, is it really more than a month since I last blogged?? I am so sorry. Things are just so busy around here. I really will try to be more regular about this though.

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A few updates from the world of dry eye eyewear...

1) Next week I'm expecting to meet with Panoptx' sales director to preview their new products coming out at the beginning of 2008. I'm excited about this and looking forward to seeing what's new. I'll post here and on dryeyetalk after I get a looksee.

2) According to a recent press release, Wiley-X is outlicensing their climate control facial cavity technology to Bushnell, who make the Bolle and Serengetti eyewear lines. Meaning, HOPEFULLY, that the same type of seal used on the current Wiley-X Climate Control frames will be incorporated in more eyewear options in the relatively near future, which should be good news for us.

3) No word on timing of the MEGs release yet but fingers crossed that they are coming soon. They won't come before they're wanted, that's for sure.

Friday, September 7, 2007

Book review: Reversing Dry Eye Syndrome (by Dr. Maskin)

"Reversing Dry Eye Syndrome: Practical Ways to Improve your Comfort, Vision and Appearance" by Steven L. Maskin. 2007, Yale University Press.

SYNOPSIS

Reversing Dry Eye Syndrome is the second of two brand new dry eye books on the market this year - the only two, in fact, ever written for the general public. I am very excited about this trend and grateful to the authors. There is a great need for public education about dry eye and particularly for better resources for the many people suffering from chronic dry eye. I hope we see more and more major publications reviewing both books. I would like to urge all dry eye patients to pick up a copy of this book and to let their doctor know about it.

In Reversing Dry Eye Syndrome
, Dr. Maskin (a full-time specialist in Tampa, Florida) covers a logical sequence of topics starting with basic eye education, how the tear film works, and the many things that can cause dry eye - some discussed in depth - and goes on to discuss diagnosis, the many treatments now available, and the home remedies and strategies dry eye patients can employ to improve their eye comfort and health.

Since this book was published just after Dr. Latkany's The Dry Eye Remedy, it is inevitable that the two will be compared.

Both books contain many practical gems - things dry eye patients can do for themselves. There is of course plenty of overlap but each book offers enough unique tips and different perspectives that they are by no means redundant. I found after reading Reversing Dry Eye Syndrome that I had unwittingly formed expectations that were not met and which in retrospect I had no basis for - I guess you could say I was expecting it to be a sort of Dry Eye 201 (deeper and more scientific). But it's really an alternative version of Dry Eye 101 and as such is certainly going to be useful to many newly diagnosed patients and even veterans who want to get a broader understanding of the causes and treatments for dry eye.

CHAPTER BY CHAPTER OVERVIEW

1. What is dry eye syndrome and who gets it?
Background information on typical dry eye symptoms, people who are most likely to get dry eye, and a 10-question self-test.

2. An overview of the eye: General information on eye anatomy, refractive errors and common eye diseases.

3. The Dry Eye:
Detailed description of the tear production parts of the eye with some handy diagrams, and descriptions of what it means for the system to break down.

4. The Causes: Listing and brief discussion of a variety of causes, grouped under the general categories of behavioral, environmental, aging, and diseases/disorders.

5. Aging and Gender: Discusses hormonal, geriatric, and medicine-related causes of dry eye.

6. Allergies, Toxicities and Other Sensitivities: Discusses allergic reactions and various types of conjunctivitis; contact dermatitis; and the relationship between ocular allergies and dry eye. Includes practical suggestions, and a handy self-test to distinguish between allergies and dry eye.

7. Contact Lenses: General information on lens types and caring for lenses, and some discussion of how contact lens wear may contribute to dry eye.

8. LASIK and Other Refractive Surgeries: Information about laser eye surgeries and how they work; questions to use when searching for a surgeon; and some comments about how laser surgery may affect dry eyes.

9. The Diagnosis: Advice on finding an eye doctor, an eye history checklist, and descriptions of testing equipment and basic tests for dry eye.

10. Treatment: This chapter begins by presenting a version of the "Delphi Consensus Approach" - a listing describing 4 levels of dry eye and treatments for each, with Dr. Maskin's modifications and additions.

11. Remedies for Home and Work: This is the most practical chapter in the book, with lots of examples and checklists of things you can do to improve your eyes at home and work.

12. Twenty Frequently Asked Questions.
Nice little synopsis of general questions related to dry eye.

Glossary: From acetylcysteine to xerophthalmia and a lot of dry eye (and general ophthalmology) terms in between.

Resources: Best suited to research-oriented readers, since it consists almost entirely of a list of medical references. Two "Helpful websites" listed (Schepens and Boston Foundation for Sight), along with the helpful suggestion of Googling for Johns Hopkins and the Mayo.

HIGHLIGHTS

- Thoroughness on many topics. On issues ranging from dry eye symptoms to causes to treatments to home remedies, there are lengthy lists with a paragraph or so explanation. While few are covered in much depth, the wide range of subtopics is valuable in giving people as many ideas as possible to pursue.

- I really enjoyed the chapter on allergies, toxicities and sensitivities. Probably the chapter that I personally learned from most.

- Eye history checklist, p. 131-133. I think this would be an excellent tool for patients to complete and take to their new eye doctor for discussion and to be placed in their medical record.

- Chapter 11 (Remedies for Home and Work) - the practical bits. You may or may not need suggestions for how to consume more canned tuna, but otherwise the checklists - esp. boxes 34, 35 and 36 - for improving dry eye at home and at work are excellent. And, wonder of wonders, he mentions rice. As an avid Rice Baggy fan, I was gratified to finally see some vindication from a doctor of this simple but wonderfully effective tool for MGD.

SHORTCOMINGS

- Lack of focus. After reading this book I felt like I walked away with more of an information collection than a message. That is not really intended as criticism - after all, the point is for readers to get the information THEY need and different people need different pieces - but I felt that clearer themes holding it all together would have been valuable.

- Could have been a little more upbeat. In my experience, people with chronic dry eye often suffer from depression and/or anxiety and are in need of encouragement, reassurance and hope. I think sometimes Dr. Maskin's diligence in repeatedly emphasizing the potential seriousness of dry eye and the urgency of getting care may be a tad hard on patients who are already distressed, particularly if - as is too often the case - they have already seen several doctors without getting the answers or relief they need.

- Extraneous information. This book tries to do a little too much for too many people, and in doing so it strays into general eyecare topics with distracting frequency and duration. For example, there is an entire chapter dedicated to refractive surgery (e.g. LASIK) full of general information. Similarly, I had been looking forward to the chapter on contact lenses, but the majority of it was very basic information about contacts and how to take care of them. On these and other general eyecare topics, I found nothing I couldn't easily find on about a gazillion websites.

- Style. It's a hazardous area to comment on since this is strictly a matter of personal taste and I don't want to put anyone off buying it because there really are many gems throughout the book. Personally, though, as a picky critic I found that the writing style detracted from my enjoyment of this book, particularly on a first reading. It was kind of slow going, a bit self-conscious, and at times comes across as somewhat condescending. Every now and then I found myself sighing over exasperatingly self-evident comments. Perhaps I'm overestimating the healthcare-book-reading general public, but I don't personally think people these days need to be told that if they get a piece of glass in their eye, they should go see a doctor, or that smoking is damaging to their general health, or that they should not put contact lenses in their mouth.

WHERE TO BUY, HOW MUCH IT COSTS

It's sold for $11.56 on Amazon, and you can purchase it together with The Dry Eye Remedy for about $22.

We don't have it in The Dry Eye Shop yet but we may at some point.

Please consider NOT ORDERING this book on Amazon. Instead, go to your local B&N, Borders or whatever, and if they do not have this book already in stock, ask them to order it. Seriously, the more copies of dry eye books around, the better for all of us - it will help raise awareness of this challenging condition.

After you read the book, come back and post your comments about it on our bulletin board (Dry Eye Talk). Also, don't forget to tell your doctor about the book if you find it helpful! You have more influence on your doctor than you think. What you share with him/her may prove helpful to other patients.

Friday, August 24, 2007

Study: Dry eyes and estrogen levels

Remarkable findings from a recent study in Italy with some very interesting implications. Emphasis mine:

Ocular surface changes over the menstrual cycle in women with and without dry eye.

Gynecol Endocrinol. 2007 Jul;23(7):385-90. Versura P, Fresina M, Campos EC. Department of Surgical Science and Transplants, Section of Ophthalmology, Alma Mater Studiorum Università di Bologna, Bologna, Italy.

Aim. To analyze whether dry eye symptoms and ocular surface parameters change during different phases of the menstrual cycle. Method. Twenty-nine women of fertile age and with regular, 26-29-day menstrual cycles were included in the study. Fourteen subjects suffered and 15 did not suffer from dry eye symptoms. Symptoms were scored by the validated Ocular Surface Disease Index questionnaire. Tear production was evaluated with the Schirmer I test and the Schirmer II test (Jones test); tear stability with tear breakup time and Ferning test; and degree of dryness by the tear function index and imprint conjunctival cytology. Degree of inflammation was evaluated with conjunctival brush cytology and concentration of exudated serum albumin in tears. Hormonal cytology procedures were applied to exfoliated cells in tears. Patients were analyzed during menstruation, in the follicular phase and the luteal phase over two consecutive cycles, and results were statistically evaluated. Results. Subjective symptoms, tear production and stability, surface dryness and inflammation were significantly related to hormonal fluctuations in the menstrual cycle. In particular, the impairment of these functions appeared to be related to the estrogen peak occurring during the follicular phase, especially in patients with dry eye. Conclusion. The ocular surface is confirmed to be an estrogen-dependent unit; clinicians should take into account these cyclic variations during examination of subjects affected by symptoms of eye dryness.


By the way, did you notice how thorough those methods were... no fewer than 9 different testing methods (1 for symptoms, 8 for clinical signs). I am definitely getting a reprint of this study which hopefully will be generous with data on how results varied amongst the different markers.

Note that the study lead (Dr. Versura) had a previous publication about this in the same journal back in 2005:

Menopause and dry eye. A possible relationship.

...In post-menopausal women endocrine changes join the aging effects in the pathogenesis of dry eye, but still it remains controversial whether estrogen or androgen deficiency or their imbalance impair ocular surface function. Another questionable issue concerns the efficacy of hormonal replacement therapy in the amelioration of dry eye symptoms and recovery of tear function, since the scientific literature stands in between a therapeutic or a promoting effect of eye dryness. ...estrogen or androgen-based eye drops represents a promising innovative treatment based upon important scientific rationale.