Recruiting for study: Omega 3 study in Houston (post-menopausal women)

Post-menopausal women over 40 needed for dry eye study

Women over the age of 40 who are past menopause can take part in a research study evaluating omega-3 fatty acids or fish oil as a treatment for dry eye.

Recruiting for study: Omega 3 study in Houston

Post-menopausal women over 40 needed for dry eye study

Women over the age of 40 who are past menopause can take part in a research study evaluating omega-3 fatty acids or fish oil as a treatment for dry eye.

Abstract: Surfactant properties of human meibomian lipids

Surfactant properties of human meibomian lipids.
Invest Ophthalmol Vis Sci. 2010 Nov 4. [Epub ahead of print]
Mudgil P, Millar TJ.
School of Natural Sciences, University of Western Sydney, Penrith South DC, Australia.

Purpose:
Human meibomian lipids are the major part of the lipid layer of the tear film. Their surfactant properties enable their spread across the aqueous layer and help maintain a stable tear film. The purpose of this study was to investigate surfactant properties of human meibomian lipids in vitro and to determine effects of different physical conditions such as temperature and increased osmolarity, such as occurs in dry eye, on these properties.

Methods: Human meibomian lipids were spread on an artificial tear solution in a Langmuir trough. The lipid films were compressed and expanded to record the surface pressure-area (Π-A) isocycles. The isocycles were recorded under different physical conditions such as high pressure, increasing concentration and size of divalent cations, increasing osmolarity, and varying temperature.

Results: Π-A isocycles of meibomian lipids showed that they form liquid films which are compressible and multilayered. The isocycles were unaffected by increasing concentrations or size of divalent cations and increasing osmolarity in the subphase. Temperature had a marked effect on the lipids. Increase in temperature caused lipid films to become fluid, an expected feature, but decrease in temperature unexpectedly caused expansion of lipids and an increase in pressure suggesting enhanced surfactant properties.

Conclusions: Human meibomian lipids form highly compressible, non-collapsible, multilayered liquid films. These lipids have surfactants that allow them to spread across an aqueous subphase. Their surfactant properties are unaffected by increasing divalent cations or hyperosmolarity but are sensitive to temperature. Cooling of meibomian lipids enhances their surfactant properties.

Abstract: Diagnosing obstructive MGD vs. aqueous deficient dry eye

I highlighted just one sentence below which I thought was quite interesting. Between aqueous deficient dry eye (naughty lacrimal glands) and obstructive MGD (naughty meibomian glands) not just the symptoms were similar BUT also the lid margins looked the same and the TBUT was similar. Phew. For a moment there I almost felt a little more sympathy for doctors who chronically overlook MGD. But only for a moment. Docs, ya gotta educate yerselves about MGD. Really.

Efficacy of diagnostic criteria for the differential diagnosis between obstructive meibomian gland dysfunction and aqueous deficiency dry eye.
Jpn J Ophthalmol. 2010 Sep;54(5):387-91. Epub 2010 Nov 5.
Arita R, Itoh K, Maeda S, Maeda K, Tomidokoro A, Amano S.
Itoh Clinic, Saitama, Japan.

PURPOSE: To evaluate diagnostic criteria for obstructive meibomian gland dysfunction (MGD) using three parameters (symptom score, lid margin abnormality score, and meibomian gland morphologic change scores) for differentiating obstructive MGD from aqueous deficiency dry eye (ADDE).

METHODS: Twenty-five eyes of 25 patients (mean age, 66.6 years) diagnosed with obstructive MGD and 15 eyes of 15 patients (mean age, 61.3 years) diagnosed with ADDE were analyzed. Ocular symptoms were scored from 0 to 14 according to the number of symptoms. Lid margin abnormality was scored from 0 to 4 according to the number of abnormalities. Meibomian gland changes were scored from 0 to 6 using noncontact meibography (meibo-score). Superficial punctate keratopathy was scored from 0 to 3. Meibum was graded from 0 to 3 according to volume and quality. Tear film break-up time was measured consecutively three times after instillation of fluorescein, and the median value was adopted. Tear film production was evaluated using the Schirmer test.

RESULTS: Ocular symptom and lid margin abnormality scores and tear film break-up time did not differ significantly between the obstructive MGD and ADDE groups. The meibum score and meibo-score were significantly higher in the obstructive MGD group than in the ADDE group. The Schirmer value was significantly lower in the ADDE group than in the obstructive MGD group. When obstructive MGD was diagnosed on the basis of three scores (ocular symptom score, lid margin abnormality score, and meibo-score) all being abnormal, the sensitivity and specificity for differentiating between obstructive MGD and ADDE were 68.0% and 80%, respectively.

CONCLUSIONS: Although the criteria were moderately reliable for differentiating patients with obstructive MGD from those with ADDE when the diagnosis of obstructive MGD was made on the basis of three abnormal scores, they do not provide comprehensive diagnostic tools for differentiating MGD, ADDE, and healthy individuals. We need to add other parameters such as the Schirmer test value and the meibum score to the diagnostic criteria to enhance their reliability for differentiating MGD and ADDE.

Abstract: Sodium hyaluronate and carboxymethylcellulose

This kind of study drives me nuts, because irrespective of the validity of the data, it never tells the real story.

Sounds like a simple proposition: Compare a sodium hyaluronate drop to a carboxymethylcellulose drop. (They're all alike, a dime a dozen, right?) And conclude that they both made people's eyes wetter. Get out. Really? And we all nod and say, I told you so, all artificial tears are more or less the same. But are they?

Back in the days (wave of nostalgia coming...) when I had a little capital and I was able to be more involved with my beloved Dr. Holly's drops, I got a little much-needed education on what goes on in these drops that never shows up on the label... or the study abstract, and probably not even in the whole paper. Take Dwelle for instance. It's povidone and polyvinyl alcohol. Big deal. There's several drops with these ingredients on the market and I think I won't hurt anyone's feelings if I say none of them has ever been thought earth-shattering. Tried one PVA drop, tried 'em, all, right? No, actually, Dr. Holly's drops have a combination of grades of PVA not used in any other drop and this combination (along with the additional polymer) creates uniquely high oncotic pressure values which is what makes his drops effective especially for those with a compromised epithelium.

So circling back to sodium hyaluronate... My industry friends say it's all about the molecular weight. All SH drops are NOT equal, just as all PVA drops are NOT equal.

Bottom line: Do your homework on drops. Don't write them off (and likewise, don't embrace them) just because of a fancy name in the active or in some cases inactive ingredients. Sometimes what's NOT on the label is more telling than what is.

Efficacy of Sodium Hyaluronate and Carboxymethylcellulose in Treating Mild to Moderate Dry Eye Disease.
Cornea. 2010 Oct 28. [Epub ahead of print]
Lee JH, Ahn HS, Kim EK, Kim TI.
From the Department of Ophthalmology, Institute of Vision Research, Yonsei University College of Medicine, Seoul, Korea.

PURPOSE: We compared the efficacy and safety of sodium hyaluronate (SH) and carboxymethylcellulose (CMC) in treating mild to moderate dry eye.

METHODS: Sixty-seven patients with mild to moderate dry eye were enrolled in this prospective, randomized, blinded study. They were treated 6 times a day with preservative-free unit dose formula eyedrops containing 0.1% SH or 0.5% CMC for 8 weeks. Corneal and conjunctival staining with fluorescein, tear film breakup time, subjective symptoms, and adverse reactions were assessed at baseline, 4 weeks, and 8 weeks after treatment initiation.

RESULTS: Thirty-two patients were randomly assigned to the SH group and 33 were randomly assigned to the CMC group. Both the SH and CMC groups showed statistically significant improvements in corneal and conjunctival staining sum scores, tear film breakup time, and dry eye symptom score at 4 and 8 weeks after treatment initiation. However, there were no statistically significant differences in any of the indices between the 2 treatment groups. There were no significant adverse reactions observed during follow-up.

CONCLUSIONS: The efficacies of SH and CMC were equivalent in treating mild to moderate dry eye. SH and CMC preservative-free artificial tear formulations appropriately manage dry eye sign and symptoms and show safety and efficacy when frequently administered in a unit dose formula.

Abstract: Theratears Nutrition

This is kind of, sort of a little bit interesting. Test everyone. Give everyone fish & flaxseed oil daily for three months. Then test 'em again. On the one hand, it sounds like very little changed for anybody in terms of clinical findings. On the other hand, 70% "became asymptomatic". WTH? I'd like to know what they were like to start with. The interesting part is, the authors' conclusions was that it may have helped tear production but didn't do a thing for the lipids or TBUT.

Pilot, Prospective, Randomized, Double-masked, Placebo-controlled Clinical Trial of an Omega-3 Supplement for Dry Eye.
Cornea. 2010 Oct 28. [Epub ahead of print]
Wojtowicz JC, Butovich I, Uchiyama E, Aronowicz J, Agee S, McCulley JP.
From the Department of Ophthalmology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX.

PURPOSE: To investigate the potential effect of dietary supplementation with omega-3 fatty acid on lipid composition of meibum, aqueous tear evaporation, and tear volume in patients with dry eye.

METHODS: In a pilot, prospective, randomized, double-masked study, patients with dry eye received a daily dose of fish oil, containing 450 mg of eicosapentaenoic acid, 300 mg of docosahexaenoic acid, and 1000 mg of flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) for 90 days. There were 2 patient visits: baseline and final. At these visits, patients completed the ocular surface disease index to score subjective symptoms, and slit-lamp examinations, breakup time, corneal staining, Schirmer type I, fluorophotometry, evaporometry, and collection of meibomian gland secretion samples for lipid composition analysis were performed.

RESULTS: A total of 36 patients with dry eye completed the study. At the end of the study, 70% of the patients became asymptomatic, whereas for the placebo group, 7% of the symptomatic patients became asymptomatic. Schirmer testing and fluorophotometry suggested that the omega-3 supplement increased tear secretion. The lipid composition of the samples collected from the omega-3 group was found to be very similar to that from the placebo group. No trends between groups were seen for other objective parameters.

CONCLUSIONS: Dietary supplementation with omega-3 fatty acids in dry eye showed no significant effect in meibum lipid composition or aqueous tear evaporation rate. On the other hand, the average tear production and tear volume was increased in the omega-3 group as indicated by both Schirmer testing and fluorophotometry.

Abstract: The economic burden of dry eye disease in the US

This is an interesting summary of estimated costs of managing dry eye. I wonder where they got their recruits? I wish somebody would recruit some DryEyeTalk members.

I suspect this study is looking at people with considerably milder dry eye symptoms than your average DryEyeTalk member or DryEyeBulletin reader. The $783 estimated total annual cost per patient supposedly covers all direct (medical, OTC, etc) and indirect costs. Geez, most dry eye patients I know spend something in that neighborhood annually just in over-the-counter products and eyewear, let alone the cost of doctor visits and prescription drugs and indirect costs like lost workdays. In fact I know an awful lot of people who spend that much on artificial tears each year.

I suppose it is progress that they've included the cost of nutritional supplements, not just drugs, but someday I'd like to see a study that includes things like night goggles and moisture chambers, since protective eyewear is increasingly being recognized as a vital tool for severe dry eye and is usually the highest dollar item on the dry eye shopping list.


The Economic Burden of Dry Eye Disease in the United States: A Decision Tree Analysis.
Cornea. 2010 Oct 28. [Epub ahead of print]
Yu J, Asche CV, Fairchild CJ.
From the *University of Utah, College of Pharmacy, Pharmacotherapy Outcomes Research Center, University of Utah, Salt Lake City, UT; and †Alcon Research, Ltd, Fort Worth, TX.

PURPOSE:
The aim of this study was to estimate both the direct and indirect annual cost of managing dry eye disease (DED) in the United States from a societal and a payer's perspective.

METHODS:
A decision analytic model was developed to estimate the annual cost for managing a cohort of patients with dry eye with differing severity of symptoms and treatment. The direct costs included ocular lubricants, cyclosporine, punctal plugs, physician visits, and nutritional supplements. The indirect costs were measured as the productivity loss because of absenteeism and presenteeism. The model was populated with data that were obtained from surveys that were completed by dry eye sufferers who were recruited from online databases. Sensitivity analyses were employed to evaluate the impact of changes in parameters on the estimation of costs. All costs were converted to 2008 US dollars.

RESULTS:
Survey data were collected from 2171 respondents with DED. Our analysis indicated that the average annual cost of managing a patient with dry eye at $783 (variation, $757-$809) from the payers' perspective. When adjusted to the prevalence of DED nationwide, the overall burden of DED for the US healthcare system would be $3.84 billion. From a societal perspective, the average cost of managing DED was estimated to be $11,302 per patient and $55.4 billion to the US society overall.

CONCLUSIONS: DED poses a substantial economic burden on the payer and on the society. These findings may provide valuable information for health plans or employers regarding budget estimation.

Restasis approved in Canada

No fanfare or press release but I just ran across a mention of it in Allergan's 3Q results.

Abstract: MMF

Mol Vis. 2010 Oct 1;16:1913-9.
Effects of mycophenolate mofetil on proliferation and mucin-5AC expression in human conjunctival goblet cells in vitro.
He H, Ding H, Liao A, Liu Q, Yang J, Zhong X.

PURPOSE: To investigate the effects of mycophenolate mofetil (MMF) on proliferation and mucin-5AC (MUC5AC) mRNA expression of normal human conjunctival goblet cells (CGCs) in vitro and to understand mechanisms of MMF in treatment of dry eye syndrome at molecular level.

METHODS: Purified human CGCs were treated with a series of graded concentrations of MMF after being confirmed by immunocytochemistry and flow cytometry. Proliferation and MUC5AC mRNA expression of CGCs were measured by Cell Count Kit-8 (CCK-8) and quantitative nested real-time reverse transcription polymerase chain reaction (QNRT-PCR at 24 h after treatment. The cell proliferation and MUC5AC mRNA expressiion were compared among different doses of MMF.

RESULTS: MMF induced a dose-dependent upregulation of MUC5AC mRNA expression (F=238.851, p<0.01) but a biphase effect on proliferation of the CGCs over 24 h of co-incubation. This biphase effect manifested as a dose-dependent increase in cell numbers with MMF from 0.25 to 2.5 ng/ml, an unchanged population of the cells from 2.5 to 10 ng/ml and a reduced population of the cells from 25 to 100 ng/ml.

CONCLUSIONS: MMF exerts biphase effects on cell regeneration and upregulates MUC5AC mRNA expression in CGCs in vitro. It appears that the use of MMF at low concentrations is attractive in dry eye (DE) treatment.

Abstract: MGD and proteins

Br J Ophthalmol. 2010 Oct 28. [Epub ahead of print]
Association of tear proteins with Meibomian gland disease and dry eye symptoms.
Tong L, Zhou L, Beuerman RW, Zhao SZ, Li XR.
Singapore, Singapore.

Aim
Tear proteins have an important role in the maintenance of the ocular surface and modulation of biological processes, including inflammation, in dry eye. Meibomian gland disease (MGD) is a condition that can increase inflammation in the ocular surface, but tear protein changes due to MGD have not been documented. This study evaluated the possible association of tear proteins with severity of MGD in dry eye.

Methods
Twenty-four patients with dry eye were evaluated. The panel of proteins found previously to be of interest and evaluated in this study were α-enolase, α-1-acid glycoprotein 1, S100A8 (calgranulin A), S100A9 (calgranulin B), S100A4 and S100A11 (calgizzarin), prolactin-inducible protein (PIP), lipocalin-1, lactoferrin and lysozyme. Tear protein ratios for each of 24 patients were calculated relative to pooled control from 18 healthy people, using isobaric tagging for relative and absolute quantification (iTRAQ)-based proteomics combined with two-dimensional-nanoliquid chromatography (LC)-nano-electrospray ionisation (ESI)-mass spectrometry (MS)/MS. The severity of MGD was clinically classified into grades 0-3 based on biomicroscopic signs.

Results
The levels of S100A8 and S100A9 were correlated to MGD severity. The level of S100A8 protein was significantly correlated to grittiness, whereas S100A8 and S100A9 were correlated to symptoms of redness and transient blurring. Lipocalin-1 was associated with heaviness of the eyelids and tearing.

Conclusions
Distinct tear proteins are associated with MGD in dry eye patients, and some proteins were associated with distinct dry eye symptoms. These findings suggest that MGD may independently contribute to the symptomatology of dry eye patients.

Minor drug updates - RGN259 and RX-10045

1) RGN259 is enrolling for a Phase II trial this quarter and the trial will take place through 2011, according to a recent news report.

2) Rexolvyx has a new partner, Celtic Therapeutics, who have an option to acquire and license RX-10045, according to a press release.

Abstract: Interferometry in evaluating tear film thickness

Am J Ophthalmol. 2010 Oct 21. [Epub ahead of print]
Interferometry in the Evaluation of Precorneal Tear Film Thickness in Dry Eye.
Hosaka E, Kawamorita T, Ogasawara Y, Nakayama N, Uozato H, Shimizu K, Dogru M, Tsubota K, Goto E.
Department of Ophthalmology, School of Dental Medicine, Tsurumi University, Yokohama, Japan.

PURPOSE: To compare tear film thickness between normal subjects and aqueous tear deficiency dry eye patients by tear interferometry.

DESIGN: Prospective case-control study.

METHODS: Central precorneal tear film thickness was measured noninvasively using an interference thin-film thickness measurement device (Quore MSPA1100; Mamiya-OP). Tear film thickness of 14 eyes from 14 normal subjects and of 28 eyes from 28 aqueous tear deficiency dry eye patients were compared along with noninvasively measured tear meniscus height, DR-1 (Kowa) dry eye severity grading, fluorescein and rose bengal staining scores, tear film break-up time, and Schirmer test results. Among dry eye patients, 13 eyes underwent punctal occlusion, and tear film thickness was compared before and after the surgery.

RESULTS: Tear film was significantly thinner in dry eye patients (2.0 ± 1.5 μm) than normal subjects (6.0 ± 2.4 μm; P < .0001). Tear film thickness showed good correlation with other dry eye examinations. After punctal occlusion, tear film thickness increased significantly from 1.7 ± 1.5 μm to 4.9 ± 2.8 μm (P = .001) with the improvement of tear meniscus height, fluorescein and rose bengal staining scores, tear film break-up time, and Schirmer test values.

CONCLUSIONS: Interferometric tear film thickness measurement revealed impaired precorneal tear film formation in aqueous tear deficiency dry eyes and was useful for showing the reconstruction of tear film after punctal occlusion surgery. Interferometry of precorneal tear film may be helpful for the evaluation of aqueous tear deficiency in conjunction with other dry eye examinations.

Abstract: from Spain

I'm just posting this one so Spanish readers (or others in the neighborhood) can take note of the authors in case they are looking for names of doctors or researchers that might take an interest in dry eye.

Ocul Surf. 2010 Oct;8(4):185-92.
The tear film and the optical quality of the eye.
Montés-Micó R, Cerviño A, Ferrer-Blasco T, García-Lázaro S, Madrid-Costa D.
From the Optometry Research Group, Department of Optics, University of Valencia. Spain.

ABSTRACT The stability of the tear film plays an important role in the optical quality of the eye. Various methods have been developed to quantify the contribution of the tear film to optical quality, including the double-pass optical method, Hartmann-Shack wavefront sensing, videokeratoscopy, retroillumination analysis, and interferometry. In addition to assessing the effect of tear film irregularities, these methods can aid in the diagnosis of dry-eye related conditions and the monitoring of therapy. This review describes the methodologies used to assess the relationship between the tear film and optical quality of the eye and summarizes the most important findings obtained with these methods with regard to the healthy human eye, the dry eye, and the effect of artificial tear instillation.

Abstract: SmartPlugs, DumbPlugs and DarnedPlugs

Almost as often as I see a new study on this brand of plugs, I hear of YET ANOTHER patient who is probably facing reconstructive eyelid surgery after having a so-called SmartPlug inexplicably go AWOL in her eyelid.

Stay away from this product - that's all I can say.

A high success rate means nothing when the consequences of being one of the minority failures is so terribly serious.

Some form of simple failure is acceptable for most medical treatments. Catastrophic failure is ABSOLUTELY UNACCEPTABLE for any dry eye treatment.

Nan Fang Yi Ke Da Xue Xue Bao. 2010 Oct 20;30(10):2370-2372.
[Application of Smart Plug lacrimal plug in the treatmengt of dry eye.]
[Article in Chinese]
Guo L, Wu XY, Yuan F, Li B.
Department of Ophthalmology, Qilu Hospital of Shandong University, Jinan 250012, China.

OBJECTIVE: To evaluate the clinical efficacy of Smart Plug lacrimal plug in the treatment of dry eye.

METHODS: Twenty-nine patients with dry eyes (58 eyes) were treated with Smart Plug lacrimal plug. All the patients were follow up for 6-10 months (average 7.8 months). Schirmer I test (SIT), tear break-up time (TBUT) and corneal fluorescein staining were used for evaluation of the clinical efficacy.

RESULTS: The SIT was 3.35∓2.60 mm and 6.35∓4.15 mm, TBUT was 3.14∓1.22 s and 5.46∓1.26 s, and corneal fluorescein staining was 2.15∓0.09 and 0.05∓0.01 before and after the treatment, respectively (P<0.05). The subjective symptoms were improved in most of the patients.

CONCLUSION: Smart Plug lacrimal plug is effective in the treatment of dry eye due to aqueous tear deficiency, and can be one of the choice of dry eye treatment

New eyewear: Ziena Oasis

Isn't this a stunning frame?

Would you believe it is also the best non-goggle Rx-able moisture chamber you can buy?

An aesthetically pleasing moisture chamber has always been a contradiction in terms. Most of us have compromised in some way or another with goggles that rate either somewhat or very high on the dorkiness scale. For prescription glasses wearers, the options are narrower (and usually uglier).

Those who can afford to slide up the scale from goggles have had to get either custom moisture chambers built for their glasses, or Micro-Environment Glasses, both of which are very good, but neither of which you would ever consider if you didn't have dry eye.

So the Ziena has arrived to fill an important niche. And you would hardly believe from the picture that it does fill it - but it does.

The frame has a silicone eyecup which attaches with several tiny little magnets. No foam. The silicone is very, very delicate and as it approaches the face curls under slightly. It forms a nice (not airtight) seal most of the way around. It's extremely comfortable. For those of you familiar with MEGs, it's kind of the reverse design in that there is a gap at the top rather than the bottom. Seemed counterintuitive to me and I really wondered how it would perform. But it was great. And once I had these things on my face I didn't want to take them off, outdoors or indoors.

The Ziena is easily the best pair of glasses I have ever had for driving. In a weeklong test, they did not fog - period. Amongst all the 7Eye and Wiley glasses I have ever used (and they are many) all of them have fogged at least occasionally when driving.

The lenses are larger than most 7Eye or Wiley glasses I've had, so my vision was better. And while the silicone eyecup is semi-opaque, it's clear/whitish and light comes through so you don't get any of the tunnel-vision effect most moisture chambers produce. These glasses are real design coup.

So, to boil it down to essentials:

PROS:

1. Beautiful.

2. Effective for dry eye protection.

3. Good vision.

CONS:

1. Price and ongoing expense. With no prescription, you're looking at a minimum of $290, and you're probably going to have to replace that silicone shield ($35) every month or two. It's new, so I really won't know for awhile how long they'll last. I'm not even really sure how to clean it.

2. Hinge placement (see note below)

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For those of you whose dry eyewear budgets are in the double rather than triple digits, don't worry, there's an excellent new product due out soon - probably before the end of the year - that I tested awhile back and really liked! So stay tuned - it'll be in the blog and newsletter when it comes.

FRAMES / LENSES

There are three framestyles: Glossy black, light tortoise, and brown fade. The one pictured above is light tortoise.

Lens options are much as for other 7Eye products:
- Sharpview if you want the basic darker lens for outdoor use
- Photochromic 24:7 lenses for indoor/outdoor (best if you want to use this at the office)
- ColorAmp Polarized
- ColorAmp grey or copper

If you need RX, you can either get a local dealer to produce it for you, get it direct from 7Eye, or purchase the frame on my site and take it to a local optician to get whatever lenses you want in it (including clear lenses).

HOW/WHERE TO BUY:

They are not yet available on the 7Eye website. So:

Local: Call 7Eye or go on their website to get local dealer phone numbers. Not too many dealers have them yet though.

Dry Eye Shop: Click here to buy or just to look at the different frame/lens combinations. I have several of these in stock including frame-only for those who need Rx (I don't sell Rx - you would need to take it to your optician). Anything not showing in stock has to be special-ordered so please allow an extra 5 days for delivery.

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NOTE re: Hinge placement:
This will probably not affect anyone except people like me whose skin is freakishly sensitive to metals (I can't wear necklaces or watches even for one day). The hinge on the Ziena is much further up on the earpiece than 7EYE's other products in order to accommodate the eyecup, so a teensy bit of the metal comes pretty close to my cheek. It's only a little, but after about a week of frequent wear my cheeks broke out. Again, I think very few people would be affected by this. I am so bummed about it because if it weren't for that, I would be wearing this full-time - yes, even at the computer at my home office!