Clinical study

[grandmajane]

Erik - Research Study

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]

study

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]

jcorbett

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]

In Severe Pain

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]

Ice and sore/dry eyes

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]

Update Rebamipide

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...