Rebamipide, finally

[Erik]

I'm a bit late in getting this out, due to that pesky job of mine, and that distracting family...

So good news and bad news, but mostly good, I think. The caveat, first though: I was on a placebo-controlled trial (1/3 placebo, 1/3 lower-dose rebamipide, 1/3 higher-dose rebamipide) and I do not know for sure what I received--could have been placebo.

Objectively, the treatment I received (for two months) increased my tear break-up time (TBUT) substantially, to nearly ten seconds on last exam (Thursday, June 2), from my normal baseline 2-3 secs. This is a big-time improvement--I don't think I've ever measured above 5 since surgery.

Also, the treatment very noticeably improved my corneal staining on fluorescein and lissamine green test. (Anyone had the lissamine green before? It stains not just your eyes/lids, but also the area around your eyes, so you end up with an Alice Cooper sort of look afterwards. But I digress...) Both tests had me with 4 areas in each eye with scores of 2 prior to treatment and only one 2-score in left eye after 2 months rebamipide. Again, substantial improvement, from 8 2-scores (higher is worse) to 1 after 2 months.

Schirmer was up a bit in right eye only: about 4 mm. Still <1 mm in left eye, which has always been the more symptomatic one.

Now the bad news: I did not feel a ton better on the rebamipide. Actually, I didn't feel any better, to be completely honest. However, I only got the drug (vs placebo) for 2 months, and most people required around 4 months to notice subjective benefit, according to the doctor and nurse with whom I spoke (and trust me--I hit them up for any info I could get out of them).

Which leads to the really bad news (for me at least, but only temporarily): I am being moved by the Army and was not given the option of "taking the study with me," so I am off trial now, and will not be able to give you any more news, good or bad, until the drug gets FDA-approved.

Bottom line, though: I had some objectively verifiable improvements in TBUT and corneal staining on this study, and the doctors and nurse i spoke with said that "lots" of patients are having objective and subjective benefits. There are about four similar drugs (mucin-enhancers) undergoing clinical trials right now, so one of these will probably be ready for primetime next year (I hope?).

Other info: my treatment was 4 drops in each eye every day, milky-white fluid, kind of like Soothe eyedrops. They did not burn, except for an occasional brief sting right on instillation (which I sometimes get with Dwelle/Dakrina as well). Generally was a comfortable drop. Worst side effect was a very bad taste in my mouth, which would not be an issue with eople who are 4x plugged/cauterized. I got used to it, but it was bothersome at first.

Again, sorry to keep you waiting on this, but Hopefully it was worth waiting for. A promising drug, I think. (I HOPE.)

[jcorbett]

test scores

Any ideas on why your test scores improved, yet you did not feel any better? It seems like you should have noticed some difference. Sorry you had to leave the study, it must have been disappointing. Good luck with your move.

[grandmajane]

Rebamipide Trial

Erik
Sorry to hear that you have to end your study. I also have bad news about the study - I became allerigic to the drug (which means that I actually received the new drug - but we don't know if it was the 1% or the 2% drug)
I found a lot of relief on the drug - I am not as light sensitive as I was and use a lot less extra refresh drops when I was on the drops. Then I started to have problems with my tounge - it would swell up and get razor like cuts on the tounge - I could hardly swallow - eat or drink when the tounge was swollen - this would come an go for a couple of weeks - then it totally disappeared. Then I started to have problems with my face - it got bright red and swollen and spread all over my face - it looked like someone totally bet me up. This also would come and go and each time it came back - I would get worse. They took me off the drug for a week and tried a steriod for a few days and started the drug up again - then I got worse than ever - so last Thursday they stopped the study for me and I go in on this Thursday to do the final eye tests and blood work and sign out of the program.
I would really recommend everyone to at least try the drug when it comes on the market - I really got some relief from it and very dissapointed when I got sick from it - I actually got 22 weeks of relief . They told me they feel they are getting great info on the study people - and hope it will be on the market in the future - but didn't know how soon. I have noticed that since I have quit the study drug that my eyes are extremely dry again and that the bright lights are starting to bother me again.
Best of luck to you Erik on your move

[Philipp_from_Germany]

Rebamipide

Hi Erik-

Thank you so much for sharing your experience with us. Sorry, that you have been reassigned and have to discontinue the trial...

However, it seems like a very positive thing that there is finally a product which has the ability to increase the tear film stability... I am just curious that you haven't gotten any symptomatic relief because - in general - any tear film that is stable for at least ten seconds (The literature indicates that the "pain"-threshold is generally at +-5secs) should provide sufficient protection...But maybe because of the significant lack in quantity of your tears (sorry to point that out) you remain uncomfortable...Have you been on restasis simultaneously?

I just have a question that may seem a little odd but anyway: Did you notice any "visual" improvement concerning what your eye looks like? To be more precise, was it any less red, swollen or less sore? I know this is silly, but it does also indicate something about the state of your eyes...

[jcorbett]

allergic

Grandmajane - do you have any known allergies outside of this drop? Have you ever had this reaction before....to certain foods or meds?

[grandmajane]

Allergies

Jcorbett
The only other allergies that I know of is pcn and vallium - I never had any problems with eye drops before - many that didn't work for me but not allergies to them

[Erik]

Hi Erik-

Thank you so much for sharing your experience with us. Sorry, that you have been reassigned and have to discontinue the trial...

However, it seems like a very positive thing that there is finally a product which has the ability to increase the tear film stability... I am just curious that you haven't gotten any symptomatic relief because - in general - any tear film that is stable for at least ten seconds (The literature indicates that the "pain"-threshold is generally at +-5secs) should provide sufficient protection...But maybe because of the significant lack in quantity of your tears (sorry to point that out) you remain uncomfortable...Have you been on restasis simultaneously?

I just have a question that may seem a little odd but anyway: Did you notice any "visual" improvement concerning what your eye looks like? To be more precise, was it any less red, swollen or less sore? I know this is silly, but it does also indicate something about the state of your eyes...

Phillipp, I have not been on restasis--they do not let you use restasis while on this study (or for four weeks prior to starting). Regarding your second question: my eyes do look a bit better. It's one of the things that the opthalmalogist has to score at the beginning and the end of the study, and he stated that my sclera (the white part of the eye) is less injected (bloodshot) than before I started the drug. I've also noticed that my eyes are definitely wetter. There were times prior to starting the study that my eyes were not "wet" in the normal sense--literally, they looked dull (instead of shiny) and I could touch them and they were just a bit "sticky" rather than wet/slimy. Since being on the study, I never had this occur.

Why I didn't feel better? I don't know, but suspect that the mucin layer is really important for comfort, and I think it takes a while for that mucin layer to re-grow.

EVEN MORE IMPORTANT, THOUGH: GrandmaJane, I had the same symptoms that you had! Swollen tongue, swollen face/lips. It happened randomly and I saw an allergist friend of mine who thought it was a Motrin allergy which I had just begun to develop. This makes more sense to me, though, and could be a showstopper for this drug (swollen tongues can lead to swollen throats, which can lead to loss of airway and death). I did not report this as an adverse event (thought it was the motrin), but I will now that I hear your story! One question: were you also taking aspirin, Motrin, naprosyn, or any other kind of pain medicine? I wonder if there is an interaction.

[Rebecca Petris]

EVEN MORE IMPORTANT, THOUGH: GrandmaJane, I had the same symptoms that you had! Swollen tongue, swollen face/lips. It happened randomly and I saw an allergist friend of mine who thought it was a Motrin allergy which I had just begun to develop. This makes more sense to me, though, and could be a showstopper for this drug (swollen tongues can lead to swollen throats, which can lead to loss of airway and death). I did not report this as an adverse event (thought it was the motrin), but I will now that I hear your story!

My goodness.

Truthfully, this is one of the most astonishing threads I have ever read and certainly a powerful testament to the usefulness, speaking broadly, of e-community (is that a word?) in medical matters.

I feel quite certain that if I had been in the trial and had had an allergic response of that particular type it never would have occurred to me that it might be attributable to the eyedrop (unless I had been previously specifically advised of the possibility) and I would not have reported it.

Thank you GrandmaJane, Erik, & keep up the great work everybody.

[jcorbett]

adverse effects

ERic...did your swollen face/tongue go away on its own? Did it clear up while you were still on the rebamipide?
Makes you wonder how many other people experienced this and didn't report it. Good reminder how careful we must be when trying different meds, drops, and seemingly innocent otc items.
I do know that when I got plugs, my eyes were definitely wetter, but it did take a couple weeks before they felt better. The doc says it takes time for the damage to heal, so it takes a while for your eyes to feel better. Perhaps something like that is why your eyes did not feel better right away.

ps...can anyone tell me how 'rebamipide' is actually pronounced???

[grandmajane]

medicines

Erik
EVEN MORE IMPORTANT, THOUGH: GrandmaJane, I had the same symptoms that you had! Swollen tongue, swollen face/lips. It happened randomly and I saw an allergist friend of mine who thought it was a Motrin allergy which I had just begun to develop. This makes more sense to me, though, and could be a showstopper for this drug (swollen tongues can lead to swollen throats, which can lead to loss of airway and death). I did not report this as an adverse event (thought it was the motrin), but I will now that I hear your story! One question: were you also taking aspirin, Motrin, naprosyn, or any other kind of pain medicine? I wonder if there is an interaction.[/QUOTE]

In response to your question about taking medicines - no - the only thing that I was able to take for headaches was tylenol. I was also having problems with my voice cracking when I was in there to see the Dr - and we didn't know if it was a cold coming (I had no other systoms at the time of a cold) or what was going on - He told me that I could also be having problems with my voical cords due to the eye medicine study - that I should watch it and if I still was having problems before I went back on Thursday to call him and let him know. Well 3 days later it turned into a cold - but I guess you now also have to watch out for the vocal cords as well as the other things that was going on - if there are other systoms they didn't tell me seeing I had so many things go wrong. I will let you know more after my final Dr visit on Thursday when I sign out of the program. I will try to find out as much info as I can for you. Hope this helps. I also think that you need to mention to your study the reactions that you had - would be interesting to know how many people are having problems with the new drugs.
Best of luck

[Philipp_from_Germany]

Rebamipide Trial

It would indeed be interesting to see the newly developed drug-dispensing nanotechnology contact lens (see my other post) being loaded with this stuff. That way, the amount of substance entering the body systematically could be reduced to a minimum and the drug would just work where it is supposed to - topically on the eye's surface...

"The new contact lens is made of a bicontinuous nanostructured polymer, into which drugs can be incorporated. Eye drops currently used to deliver most ophthalmic medications usually mix with tears and drain into the nasal cavity, where they can enter the bloodstream and cause adverse side effects. In addition, dosage through eye drops may be inconsistent. Delivery of medications through the new contact lens can be much more precise and controlled."

[Philipp_from_Germany]

Rebamipide

@ Erik

Have you been diagnosed with mucin deficiency, as well?

I am asking this because rebamipide is supposed to be a mucin stimulator and you said your TBUT is up to 10 secs now. Maybe you have discussed this with your eye doc?

[dianat]

Erik,

I've been watching this thread with interest, excitement and disappointment. I truly hope that there are perhaps other drugs in the same class as Rebamipide or that work the same without causing the adverse reactions...and such dangerous ones. I mean, I could live with a little rash in some hidden place, but swelling of the tongue and face?! Yikes.

Still, I will hold out high hopes that we are on the right track with a mucin stimulator such as Rebamipide. You are cauterized in just two punctae, is that right? I'm curious if Grandmajane is plugged or cauterized. Would systemic allergic reaction be less likely in those who are all plugged up?

Lastly, I know you have a lot going on with your move and such. Thanks for continuing the study as long as you did, despite the side-effects and your lack of time. I am quite certain the intentions of your participation were as much to benefit all of us as for yourself. Thanks for that.

Diana

[Erik]

Diana,

Thanks for your kind words. Please don't be too discouraged. I have reported all of the above, was actually called back to the study site for blood tests and another physical, and the nurse told me this is the first they have heard of this, and they have enrolled quite a few patients (around 20). They have had way more patients who are getting benefit from the drug than those who had adverse reactions. In the other studies of this drug, I couldn't find much angioedema as a side effect. Maybe grandmajane and I are just sensitive.

I wouldn't write off this drug--and especially this class of drug, "mucin-secreters"--just yet. I'll bet these help a few DEZers when all is said and done.

[Annie]

I'm a bit late in getting this out, due to that pesky job of mine, and that distracting family...

So good news and bad news, but mostly good, I think. The caveat, first though: I was on a placebo-controlled trial (1/3 placebo, 1/3 lower-dose rebamipide, 1/3 higher-dose rebamipide) and I do not know for sure what I received--could have been placebo.

Objectively, the treatment I received (for two months) increased my tear break-up time (TBUT) substantially, to nearly ten seconds on last exam (Thursday, June 2), from my normal baseline 2-3 secs. This is a big-time improvement--I don't think I've ever measured above 5 since surgery.

Also, the treatment very noticeably improved my corneal staining on fluorescein and lissamine green test. (Anyone had the lissamine green before? It stains not just your eyes/lids, but also the area around your eyes, so you end up with an Alice Cooper sort of look afterwards. But I digress...) Both tests had me with 4 areas in each eye with scores of 2 prior to treatment and only one 2-score in left eye after 2 months rebamipide. Again, substantial improvement, from 8 2-scores (higher is worse) to 1 after 2 months.

Schirmer was up a bit in right eye only: about 4 mm. Still <1 mm in left eye, which has always been the more symptomatic one.

Now the bad news: I did not feel a ton better on the rebamipide. Actually, I didn't feel any better, to be completely honest. However, I only got the drug (vs placebo) for 2 months, and most people required around 4 months to notice subjective benefit, according to the doctor and nurse with whom I spoke (and trust me--I hit them up for any info I could get out of them).

Which leads to the really bad news (for me at least, but only temporarily): I am being moved by the Army and was not given the option of "taking the study with me," so I am off trial now, and will not be able to give you any more news, good or bad, until the drug gets FDA-approved.

Bottom line, though: I had some objectively verifiable improvements in TBUT and corneal staining on this study, and the doctors and nurse i spoke with said that "lots" of patients are having objective and subjective benefits. There are about four similar drugs (mucin-enhancers) undergoing clinical trials right now, so one of these will probably be ready for primetime next year (I hope?).

Other info: my treatment was 4 drops in each eye every day, milky-white fluid, kind of like Soothe eyedrops. They did not burn, except for an occasional brief sting right on instillation (which I sometimes get with Dwelle/Dakrina as well). Generally was a comfortable drop. Worst side effect was a very bad taste in my mouth, which would not be an issue with eople who are 4x plugged/cauterized. I got used to it, but it was bothersome at first.

Again, sorry to keep you waiting on this, but Hopefully it was worth waiting for. A promising drug, I think. (I HOPE.)

Hi there, thanks for your information. I have had dry eyes for 4 years. It started with erosion on my cornea-extremely painful. I have tried so much stuff, I just get weary. I am currently in a clinical trial screening phase for a drop by Novartis. Not FDA approved yet but could be promising. I take doxycycline 100 mg per day, erythromycin ointment at night and bion tears in between. I have had so much pain and suffering in all of this I could "cry"- if that would only help hahhaha. Well the study medicine is supposed to be the equivalent of Restasis without the burning. I hope I qualify. Keep in touch, thanks again Annie.