Clinical study

[grandmajane]

Hi - I'm new to this site
I have very servere dry eyes - in fact I have had my tear ducts sealed shut in order to keep the eye drops in (I no longer produce any tears and the corners of my eyes stiched shut so that I get less light in my eyes )- I have been on a lot of different drops and eye gels and still no luck - I applied to be in an eye study for 2 new drops that they are trying to get FDA approved - after many interviews I was accepted and the study lasts for 26 weeks of new drops. If the FDA approves this new medicine - they hope it will be on the market some time in the next year - Otsuka dry eye research is doing the study - I have a phone # to call if someone is interested in calling to try to get into the study - it is 1-866-393-7379. With the study if you are accepted you don't know for the 26 weeks if you got the new drug or the plasebo drug - they tell you after the study is over. I was wondering if anyone else had eyes this bad - I 'm the 3rd level of sjogrens - Would love to hear from you
Grandmajane

[Rebecca Petris]

Hi Grandmajane! Welcome to Dry Eye Talk!

Wow, cautery AND tarrsorhaphy... you've been through a lot with this.

I really appreciate your post... this is exactly the kind of thing we're hoping for, to get the word out about what studies are going on. I hope you don't mind I moved it into a new thread so it will be more visible, for those who may be interested in participating. I will call and try to get some more details about this to post.

[rhohltjr]

Rebecca,

Is there any study being done on trying to quicken (or start) the nerve
regeneration in the corneas of patients after LASIK? I was prescribed
a suppposedly mild steroid drop just before, and after my Lasik. I can't say it did even as much as the Restasis.


Robert.

Rebecca, please feel free to move my posts anywhere you like. I try to place them in appropriate areas however, sometimes they would be better suited somewhere else.

[Rebecca Petris]

Robert,

Work has been done in the area of Nerve Growth Factor (NGF) for years now, mostly in Europe I think, but I'm not sure how much if any has been done on human subjects. Honestly, I am not well read in that area at all. I think that one possible source of info is the forum archives at VSRN (formerly SurgicalEyes) here.

It's on my list of things to learn more about and I am also hoping to get as much as possible of the latest NGF scuttlebut during the Madrid meeting next month.

[Rebecca Petris]

Here is a link for the site advertising the clinical study Grandmajane mentioned:

www.eyesdry.com

I spoke with a coordinator this afternoon, they are going to work on putting together some more information for us to post here about it. Thanks again GrandmaJane for the lead!

[dianat]

Grandmajane,

What a story yours is. I am also suffering, but from post refractive surgery dry eye. I do not envy the lengths to which you have gone to find comfort. Thanks for the info on the study. I may give them a call.

Have you tried Dr. Holly's eye drops? They're described on this site. Many, many peopel have benefitted form them.

Dianat

[grandmajane]

Dianat
No I have not tried Dr Holly's eye drops - I just found this site a couple of days ago - When I was going to the eye institute - I had a very rare eye infection under the eye lids and could hardly see- lights were a killer for me - as was seeing in general - they kept trying all different kinds of medicines and drops - with no success. I went thru 4 sets of plugs and still no luck so then they decided to do the 2 surgerys. That helped some what - but I still have a lot of problems with bright lights and the sun - in fact I have not been able to drive a car since the 2nd week of March last year. The other thing that might help others out there is - in July of last year my eye dr told me of a new pair of sun glasses that were out there and that I had to get ahold of them and use them all the time. What they are is sun glasses that Harley riders use for keeping the wind and dust out of their eyes - for people with dry eyes - they are now using them for severe dry eye patients - to help keep the drops in your eyes longer to give you longer relief. I use them all the time when I go out and especially at nite at the car lights just about blind me.
You have to go to a Harley Davidson dealer to try on the different style of frames on - then they give you a form to fill out - you then go on the internet to pick out the different types of lenses that you want (color and different types of darkenss) If you go the Harley Davidison site they will tell you if there is a store near you to go. Any way the name of the glasses is Panoptx - www.panoptx.com - 1-925-484-0292 - FAX 1-925-484-0263 - if you have a prescription you will need the prescription to give them - once you order them - you can not return them - I paid $490.00 for them and it was money well spent - and you can use it on your taxes. They look like regular sunglasses - but they have rubber inserts that go around your eyes to protect them and keep the medicine in longer. This is the best thing that has happened to me since this all started besides the research study. I REALLY RECOMMEND LOOKING INTO THE GLASSES IF ANYONE IS REAL SENSITIVE TO LIGHTS AND NEEDS TO KEEP DROPS IN LONGER . HOPE THIS INFO WILL HELP SOME OF YOU

[Rebecca Petris]

Panoptyx has indeed proven a terrific resource for a lot of patients with severe dry eye, both in terms of sealing in moisture and protecting photophobic eyes. I first heard about them on SurgicalEyes way back when. Thanks for posting phone etc details here!!

[Cindy]

Hi grandmajane and welcome! I am a confirmed goggle-wearer. I have one pair each of Harleys, Panoptx and Wiley-X . I've been known to search out and post about goggles once or twice . You might be interested/entertained in looking at some of the varieties of goggle/eyewear I have found and posted on LaserMyEye's bulletin board: http://www.lasermyeye.org/forums/sho...ooglin+goggles

I've recently tried Tranquileyes. They are a kind of night-time/resting moisture sealing goggle/sleep mask. In other words, you can't see with them on as the ''lens' part is a solid peice of plastic. Not sure yet if I like them or not but I've been playing around with them.

[Erik]

Just was successfully prescreened for the "eyes dry" study today. Turns out that you have to live within 50 miles of a treatment facility. The first person I spoke with asked my zip code and said that I didn't qualify. After thinking about it, I thought that I would call back and let them know that I am willing to travel, and would they sign me up anyway? The nice person with whom I spoke told me that the study is about 70 miles from me, and agreed to sign me up for the pre-screen.

The drug (I learned from doing some research) is rebamipide, and is in two phase III clinical trials right now, of which this is one. I am a cynic when it comes to this stuff, but for what it's worth, this drug does look promising--treats underlying cause of dry eye by stimulating receptors to secrete tears components, rather than just treating the symptoms. The fact that it is in a phase III means that it has shown pretty convincing preliminary results (in phase II trials), and is now being tested on a large scale to guage the degree of benefit (if any).

For the uninitiated:

Phase I = just checking if the drug is safe. Benefit is a secondary consideration. Usually 10-25 patients.

Phase II = larger trial, usually single arm (i.e., no placebo group), which looks for efficacy of the treatment. If successful, it goes to a large, expensive phase III trial, which is multi-center (sometimes multinational), placebo or stanard-treatment controlled, and generally will lead to or nix the chances of FDA approval. A drug company has to believe in a drug to be willing to pay the cost of a large phase III trial.

The other promising drug currently in phase III is diquafosol (a P2Y2 receptor agonist--makes eyes secrete lipid, mucin, water). Prelim results have ranged from very good to mediocre, and FDA approval is not a sure thing at this point with that one.

--Erik

[dianat]

Erik,

Thanks for posting all of this, Erik. I'm glad to know. I'd read the post about the trial and kind of forgot about it. In what state is the study? Maybe I live closer than I think.

To be honest, I can't decide whether I should be participating in things like this. Living day to day in pain takes a lot of energy. Adding a trip like this sounds like a lot of stress.

Still, if I can be convinced it's for the "good" of all uncomfortable dry eye patients, I would do it and be willing to travel. Maybe I'll look into it.

Diana

[kdc66]

If you want to review the latest dry eye research than go to a web site called ARVO: http://www.arvo.org/root/index.asp. Go to the 2005 abstracts and than the advanced section and in the sessions title select dry eye treatment. I will try to post some of the interesting articles since there are probably 25-30.

Anyway, Eric had mentioned a study on Rebamipide. Here is the presentation on the results they will be doing in May at the ARVO meeting: Eric, I live in Maryland-where are they doing the testing?


Abstract Title: Multicenter, Randomized, Double-Masked, Dose-Response, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Rebamipide (OPC-12759) Sterile Ophthalmic Suspension in the Treatment of Dry Eye
Presentation Start/End Time: Monday, May 02, 2005, 3:00 PM - 4:45 PM
Location: Hall B/C
Reviewing Code: 164 dry eye disease - CO
Author Block: P.C. Donshik1, G.Foulks2, M.Monica3, P.Zhang4, A.Tano5, S.Nakatsu4, S.Bramer4. 1University of Connecticut Health, Bloomfield, CT; 2Ophthalmology, University of Louisville, Louisville, KY; 3Tulane, New Orleans, LA; 4Otsuka Maryland Reseach Institute, Rockville, MD; 5Otsuka Pharmaceutical Company, Osaka, Japan.
Keywords: 461 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled, 481 cornea: tears/tear film/dry eye, 496 drug toxicity/drug effects
Purpose: To evaluate the safety and efficacy of rebamipide ophthalmic suspension 0.5%, 1% and 2% for the treatment of dry eye.
Methods: This was a multicenter, randomized, double-masked, dose-response, placebo-controlled, parallel-group study that evaluated the safety and efficacy of multiple doses of Rebamipide ophthalmic suspension instilled into both eyes for 12 weeks. After a two week run-in period a total of 200 subjects with signs and symptoms of dry eyes were randomized to 4 treatment groups. The primary objective endpoint was fluorescein corneal staining (FCS). Secondary objective endpoints included lissamine green conjunctival staining (LGCS) and Schirmer’s test. The primary subjective endpoint was the subject’s primary ocular discomfort (POD), defined as the subject's most bothersome symptom, identified at screening. Severity of individual dry-eye- related ocular symptoms and the subject's overall treatment impression at week 12 were secondary subjective endpoint.
Results: Compared to placebo at week 12, subjects taking 2% rebamipide showed superiority (p-value<0.05) or favorable trend (p-value<0.1) in mean change from baseline (CFB) for 1)FCS score (p=0.076; p=0.015 at week 6). 2)POD (p=0.044). 3) LGCS (p=0.070). and 4) the individual symptom severity scores of gritty/sandy sensation (p=0.015), burning/pain (p-0.003) as well as the overall treatment impression scores (p=0.044). The 2% rebamipide group was statistically superior to placebo group in mean CFB for Schirmer's test at Week 2(p=0.002) and Week 8 (p=0.034). The safety profile of rebamipide was favorable. No deaths or treatment-related SAE were reported. The incidence of treatment-related eye disorders in the rebamipide treatment groups was less than the incidence of treatment-related eye disorders in the placebo group. Results from other safety assessments were not clinically meaningful.
Conclusions: All three concentrations of rebamipide ophthalmic suspension were well-tolerated and efficacy was demonstrated in dry eye subjects. The concentration of 2% rebamipide appears to be the most effective concentration. There were no serious safety issues in this trial.
Commercial Relationship: P.C. Donshik, Otsuka Maryland Reseach Institute F, C, R; G. Foulks, Otsuka Maryland Reseach Institute F, C, R; M. Monica, Ostuka Maryland Reseach Institute F, C, R; P. Zhang, Otsuka Maryland Reseach Institute E; A. Tano, Otsuka Pharmaceutical Company E; S. Nakatsu, Otsuka Maryland Reseach Institute E; S. Bramer, Otsuka Maryland Reseach Institute E.
Support: None.

[Cindy]

I'd never heard of 'rebamipide'. I did a google search. This is a Novartis product.
Media release:
MEDIA RELEASE - COMMUNIQUE AUX MEDIAS - MEDIENMITTEILUNG
http://dominoext.novartis.com/NC/NCP...3?OpenDocument

Novartis obtains rights from Otsuka to develop new treatment for dry eye

· Novel mechanism of action expected to enhance tear secretion and increase mucin levels covering conjunctiva and cornea

· Over 22 million patients visit ophthalmologists each year seeking treatment for symptoms of dry eye

Basel, February 7, 2005 – Novartis announced today that it has in-licensed rebamipide, an investigational treatment for dry eye, from Otsuka Pharmaceutical Company, Ltd. Currently being tested in two Phase III studies in the US, rebamipide is expected to demonstrate a novel mechanism of action to enhance tear secretion and increase the levels of mucin covering the conjunctiva and cornea of the eye.

Dry eye is a condition characterized by a patient's inability to produce enough tears or the appropriate quality of tears to keep the eye healthy and comfortable. There are currently 22 million patients who visit an ophthalmologist worldwide for dry eye symptoms and many more who self-treat or do not treat their condition at all.

"As dry eye can have many causes and affects a large and growing patient population, there is a high unmet medical need and opportunities exist for several new pharmacological treatment approaches," said Flemming Ornskov, MD, President of Novartis Ophthalmics. "We expect rebamipide to provide distinct advantages to patients over currently available products."

Dysfunction in the delicate balance in the tear film may develop from aging, systemic inflammatory diseases, ocular surface diseases, or different medications. Palliative treatments for dry eye include artificial tears, which patients can self-administer four or more times per day. Unlike artificial tears, which simply lubricate the eyes and help maintain moisture1, rebamipide provides a new and unique pharmacologic approach to treatment of dry eye by increasing mucin secretion. It is expected to increase tear quality and may improve corneal health.

"Novartis sees promise in rebamipide's novel ability to treat dry eye," said Ornskov. "With this in-license agreement, we expect to be able to offer general ophthalmologists a well-rounded dry eye product portfolio that we hope will elevate the standard of treatment worldwide."

Under the agreement, Novartis will obtain an exclusive license with the right to sub-license the compound globally, excluding Japan and selected Asian countries. Novartis will pay an upfront fee and annual royalties. The terms of the agreement were not disclosed.

The foregoing press release contains certain forward-looking statements that can be identified by terminology such as "will," "expected to increase," "expect to provide," "may improve," "opportunities exist," "sees promise," "expect to be able," or similar expressions, or by express or implied discussions regarding the potential that rebamipide will be approved for marketing, or regarding any potential revenues from rebamipide. Such forward-looking statements involve known and unknown risks, uncertainties or other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectations relating to rebamipide could be affected by, among other things, uncertainties relating to clinical trials; unexpected regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81 400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

References
1 American Academy of Ophthalmology. Dry Eye. 2003
http://www.medem.com/medlb/article_d...1ED&sub_cat=37
# # #

Contacts

Laurie Wooding
Novartis Ophthalmics
Tel +41 61 697 9879 (CH)
or +1 862 778 2104 (USA)
mailto:laurie.wooding@pharma.novartis.com

Lisa Richert
Novartis Global Media Relations
Tel + 41 61 324 3543
or +41 61 324 2200
mailto:lisa.richert@group.novartis.com

[Erik]

[QUOTE=kdc66]If you want to review the latest dry eye research than go to a web site called ARVO: http://www.arvo.org/root/index.asp. Go to the 2005 abstracts and than the advanced section and in the sessions title select dry eye treatment. I will try to post some of the interesting articles since there are probably 25-30.

Anyway, Eric had mentioned a study on Rebamipide. Here is the presentation on the results they will be doing in May at the ARVO meeting: Eric, I live in Maryland-where are they doing the testing?
[QUOTE]

The clinic I am going to is in Fredricksburg, VA, about 1 hour south of DC. A bit of a haul for me (I live 10 minutes north of DC), but will be well worth it if this stuff works (though I have a 33% chance of being in the placebo group). Even if not, I'll at least know that I tried. Somehow I get comfort in knowing that I am putting up a decent fight...

[Erik]

Oh, and one other thing: you get paid to be in this trial. Not that it's a lot, but perhaps a moral victory to actually make (rather than lose) money due to our post-lasik woes. Probably around $1000, I'm guessing, given the amount of clinic visits (12), lab visits (4), and a daily diary-by-phone--I'll let you know.

[grandmajane]

Erik
CONGRATULATIONS IN GETTING INTO THE EYE STUDY I have been in the study for 10 weeks now in the Milwaukee area - so far I am the only one in the area that meets all the requirements or as they told me the only one with the worst dry eyes in the area that they could find. How long have you been in the program? Do you see any kind of relief from the drops? I found that I'm not quite as sensitive to bright lights as I was - even though I still need to use my dark glasses in bright lights and at night for car lights. Some days I can get away with 2-3 extra drops besides the study drops and then the next time I might use as many as 7-10 extra drops a day. I can't decide if I have the new drug or not or the plasebo drug.(my eyes are extremely dry and damaged from sjogrens ) I asked the Dr that I see if they thought I might have one of the new drugs and their answer is they don't know until the end of the study and because my eyes are so damaged its really hard to tell one way or another.
You mentioned that we get paid for the study - what a nice bonus - free eye drops and get paid for it - and possible a new drug to help us all out (thats the real bonus) I don't know if they gave you the list of payments for being in the study or not but here it is:
VISITS 1-4 $25.00 VISITS 5-6 $50.00 VISITS 7 $75.00
VISITS 8 $100.00 FOLLOW UP VISIT $25.00
I hope you find some relief on the program - I'm keeping my fingers crossed for some good results for all of us - any new drug coming out is a plus for all of us. Please let me know how you are doing on the program - I'm really interested to hear from you
Grandmajane

[Kyle]

Wow, you guys are a wealth of information and you provide so much hope for all of us stuggling. Eric, I'm sure you will do this, but once you know if those medicines are approved and where we can get them can you pass it on to all of us? I'm sure most of you are like me...willing to try anything at this point.
Just think..maybe there will be some day when a web site like this will no longer be necessary. Wouldn't that be wonderful?!

[Erik]

GrandmaJane,

I am starting the study tomorrow--cross your fingers for me that

a) I will not get placebo
b) the drug will work for me (and later for all of the suffering souls on this board)

Actually, if "b" is true, I don't care so much about "a."

I will keep all of you posted.

Kyle: I am a die-hard Red Sox fan. I believe that miracles can and will happen, and that most if not all of us will one day be pain-free. We ain't there yet, but one step at a time. To quote dianat, "God bless rebamipide!"

[jcorbett]

If this study shows that the drug is successful, how long does it take to get it to market? Years? Anybody know?
If you people in the study do have the drops (not placebo) and they work for you, can you continue to get them after the study is over? I assume it will take a while to get it approved and marketed, but I don't know much about these things.

[Erik]

I do cancer trials, which are a bit different (they are considered by the FDA to be life-saving drugs, though often, they are "merely" life-extending). In our trials, within 2-3 months after a successful phase III trial, the drug will hit the market.

I'm not sure how long it would be for a dry-eye drug, but I wouldn't think much more than double that (6 months?) for a drug that s found to be clearly effective and (equally importantly) clearly safe.

Study patients are sometimes alowed to continue study drig after the study ends, and in some cases (depending on trial design) even the placebo patients can get study drug, but this depends on the trial and its results. Any questions about safety, and the drug will be unavailable until the FDA deliberates.

[grandmajane]

You asked about the study drugs that we are using in the research study - I asked when I started the program - that when the program is over for me would I would be able to continue to use the drops until they are FDA approved because I was doing the study - the answer was NO - that the drops were only available thru the study - but they were hoping to get an answer if the drug would be approved within 6 months to a year after all the study was done. The only thing I don't know is - how long after I get done with the study will it take for all the studies to be done and then for the FDA to make the decission. I was told the day after the study was over for me then I would have to go back to using only refresh tear drops again. I'm really keeping my fingures crossed for the drug - I have seen some relief on the drops - will let you know more as it happens for me - O! you asked what area we were in for the study - I'm in the Milwaukee area
Grandmajane

[Kyle]

Cindy,
You talked about the tranquileyes in a previous e-mail....how is that going? I'm curious because I taped hard, plastic cylinders to my eyes for about 2 months, but quit after I kept ripping off my eyebrows. I now find that I'm waking myself up because I'm scratching my eyes so much in my sleep. I'm scared I'm going to damage something without even knowing it. Do they help? Are they comfortable? How much do they cost?

Also Erik, loved your comment about the Red Sox! I am formerly from Boston so I know how you feel. Gotta say, your positive attitude helps keep me going. I pop on to this website first thing in the morning to get my inspiration from all of you..and then again last thing at night so I can have positive thoughts in my head before I go to bed at night. Thanks for the pep talk(s)!

[Cindy]

I don't find Tranquileyes comfortable. http://www.eyeeco.com/ The idea is good but they are too tight and put too much pressure on my eyes. The cost for what I tried is $65. My personal opinion is that a nice warm rice baggy and a $3 night mask when you're ready for bed is better. http://www.lasermyeye.org/patients/des/lidtherapy.html
Scroll down to "How do I do Hot compresses?".

Or here: http://www.dryeyezone.com/faq/lidtherapy.html

[Kyle]

Thanks for the info Cindy.

After playing phone tag for a week with the Dry Eye study woman I finally talked to her this morning and completed the survey. She was so nice! Unfortunately I didn't qualify for the study. She said she thinks it's because I had my lasik surgery within the past year or because of the fact that I am currently using Restasis. They are doing a study in Los Angeles, so if any of you live there try to get in on this.

I guess it's now up to you guys to keep us posted on this Rebamipide (sp?) suspension theory. She said the early testing has been very positive. Erik, be sure to let us know how it goes, okay?
Good luck!

[Annie]

Hi - I'm new to this site
I have very servere dry eyes - in fact I have had my tear ducts sealed shut in order to keep the eye drops in (I no longer produce any tears and the corners of my eyes stiched shut so that I get less light in my eyes )- I have been on a lot of different drops and eye gels and still no luck - I applied to be in an eye study for 2 new drops that they are trying to get FDA approved - after many interviews I was accepted and the study lasts for 26 weeks of new drops. If the FDA approves this new medicine - they hope it will be on the market some time in the next year - Otsuka dry eye research is doing the study - I have a phone # to call if someone is interested in calling to try to get into the study - it is 1-866-393-7379. With the study if you are accepted you don't know for the 26 weeks if you got the new drug or the plasebo drug - they tell you after the study is over. I was wondering if anyone else had eyes this bad - I 'm the 3rd level of sjogrens - Would love to hear from you
Grandmajane

I have ocular rosacea and have severe pain at the present time due to an erosion on my cornea. My eye doctors say I do not produce the oily film that keeps the tears from evaporating. I use erythromycin ointment, bion tears and baby shampoo scrubs twice a day. I cannot get any real relief for the past 14 days. I am so desperate. Now the eye doctor put me on a steroid drop and wants me to start restasis again for the third try. My eyes burn badly wiith restasis but he states the steroid will help with that burning. Any suggestions would be greatly appreciated. Annie

[dianat]

Annie,

I posted elsewhere that you need to look into pain meds. I also think you might consider using ice on your eyes. It can really help those painful times. Obviously we still need to be doing the heat for the sake of those meibomian glands, but ice offers relief and is an anti-inflammatory.

[REDEYES]

I have read somewhere that steriod drops are sometimes prescibed to relieve the burning from restasis. But you cannot be on steriod drops for very long. Has your doctors prescribed Doxycycline. Doxycycline with warm compresses and massages can help if your oil glands are clogged up which I guess they might be because of the rosacea.

[Lucy]

I must second Diana's post about the ice. I have been at this a long time. Sometimes the pain (especially in one eye) is unbearable. I do have pain meds from my GP, not my eye doc. However, when I am able and need to, I get my gel icepack from the freezer and lie down with it over my eyes. It is instant relief for me. Too bad I just can't live life lying down with ice over my face, but it's not practical. I actually tried putting the heating pad over one side of my face one night the one eye was hurting so bad. It made it worse. Duh, won't do that again. I do use warm/hot compresses and do lid scrubs. But, when you're really hurting--try a frozen gelpack. I have one with velcro covering. I can wrap it around my head covering my eyes. Hubby thinks I'm nuts. Hopefully, if I was ever confronted by a middle of the night burglar, he'd be scared off.

[Philipp_from_Germany]

Hi Dr. Erik-

Are there any good news about your rebamipide trial?

My university-opthalmologist has told me that they are conducting tests in Euope as well and it does look promising, especially concering TBUT performance. It seems like this would be the first product to actually "thicken" the tear film by releasing more mucin.

Loved to hear about your experience so far..

Philipp

[Erik]

Philipp,

I have been quiet about my experience on the study until I get a bit more objective data under my belt, but plan to break my silence next week after I see the eye doctor on Monday, and get a fresh set of TBUTs, Schirmers, etc.

Sneak peek: this is indeed a promising drug, which I hope (and believe) will eventually knock a few names off of the list of the suffering.

And just plain Erik is fine...