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What are the results of Restasis testing and cyclosporine of treatment of chronic dry eye disease?

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RESTASIS® (Cyclosporine

In this segment dr. karl g stonecipher of greensboro north carolina reviews with us the results of a study examining the use of wrist aces in the treatment of chronic dry eye and the positive implications for lasik patients one of the things that i found with wrist asis when we first started using and about two years ago this time was we confined it really to the

Dry eyed patient population the chronic dry eye patient that came in that had been in your practice forever you didn’t really have anything to offer him that would increase their tear production and what the study showed that we not only increased tear production we increase their shermer scores and we also decrease their corneal stain now looking at that we said

Okay well let’s take it one step further and we decided in the lasik dry population would this be a benefit and it made sense me and my lasik patients were in their early to mid 40s the average age being around 43 and we thought well many of the patients are female who we knew that wrist asis was a positive thing for and so the perimenopausal female who was coming

In for lasik was an easy transition to wrist a sis so then i took it one step further and i thought okay how can i categorize the patients and primarily what i did was i categorize them into mild moderate and severe now the mild patients they may get by with just using some tears postoperatively or they may get by with just symptomatic relief when they need it not

On a you know regimented frequency but with the moderate patient we found that we ran into more issues postoperatively so some of these patients we started looking back at and we decided well hey what if we could use the stasis before surgery in this patient population what if we could do some things to improve their tear film roughly 40% of americans will say that

At some point time to have a dry eye and 12 million or 14.4% of all americans that are greater than 48 years old will report some sort of a dry eye and roughly 3.5 million or 7.8 percent of all females over the age of 49 years old will report some sort of dry so this is not something that we don’t see as an ophthalmologist on a routine basis it’s a problem and the

Lasik patient is you’ve got that d innervation with the making of the flap once the flaps made your cutting across those corneal nerves that basically say to the lacrimal gland through the brain that my eyes dry lacrimal and amin need to produce more tears and subsequently that’s done well that reinnervation we’re seeing occurs within somewhere the forward a six

Month period so i see a lot of these patients using the drops for a short term maybe between four and six months but there’s some of the more severe dry eye patients it’ll stay on it for a longer period of time and maybe a year or more i found that lasik was working so well in this group that we thought well is it real you know in the real world is this working

Like we believe it’s working or is this just us given a drop to an individual and and it’s helping them but maybe not helping them to extent we thought so we took that patient population and we started this study which we presented today and really looked at lasik patients over time preoperatively we want to see if subjectively they were reporting dry eyes we had

The ocular surface disease index which is a group of questions which allowed us to kind of categorize a patient in a mild or moderate severe but we want to see if that helped us really get the patient where we thought they needed to be number one and then number two we thought well we’ll pick some other questions and ask them at baseline prior to using wrist aces

And then at the 30-day market of the 60-day mark we were going to see how they perform and it was amazing at how their daily activities of living were improved now what we wanted to do was look at the symptomatic relief in the chronic chronic dry eye patient with wrist asis in a real world study and the participants were basically individuals that came in and said

I’m having issues and when we looked at them we found subjective and object of finding that allowed them to be enrolled in this study participants in the study were prescribed at twice a day dosage of rosacea cyclosporine point zero five percent ophthalmic emulsion they were interviewed by telephone surveys at baseline 30 and 60 day intervals participants were

Asked to rank symptom severity and impact on daily activities artificial tears were permitted as needed when we look at the demographics or the gender obviously the overwhelming majority is female at 68 percent with male making up 32% of the population with regards to age the main population was the 45 to 64 year old and over half the cases and then break down in

My lasik population of 25 to 44 where my average age of the lasik patient is around 43 years of age if we look at the length of time with chronic dry eye almost 80% reported that this had occurred within the last two years so obviously many of these patients that come in will be reporting the dry eye and they’re coming in for a refractive procedure because maybe

They can’t wear their contact lenses anymore and the association’s being made we went ahead and looked at additional characteristics 20% roughly of the population had no lasik and they were just a typical dry eye patient we kind of stratified those and then 80% had had lasik and we looked at risk factors for chronic dry eye such as menopause that were specifically

Asked to the female patients we saw that in 17% of the population in the know lasik category we had one sugar and syndrome patient and one rheumatoid arthritis patient we did not see lupus in any of the patients in this doctor stonecipher was a participant in the initial 2001 and 2002 wrist aces clinical trials for fda approval the results of the initial studies

Indicated that there was a delayed response that it took four to six months for symptom relief this subsequent real-world study indicated that symptom relief occurred in as little as three weeks now when we looked at the symptom severity and the impact on the daily life in the lasik subgroup we saw before treatment it was about four point five seven and after just

30 days it reduced to three point seven one so we had roughly a twenty percent decrease in symptom severity within 30 days again if we look at the mean act of dry eye on daily activities of living the rate was at 4.0 and it reduced to two point three six was really a roughly forty percent decrease in the impact of dry on daily activities now this was an interesting

Note we asked them if they and they were not asked to stop their their artificial tear usage they were still told to use it as they wanted to and we asked them what happened with their artificial tear use and before treatment the mean artificial tear use was six point four times per day which goes along with this dry population and sixty-seven percent again two

Thirds decreased their level of tears which says that the drops doing something in a short amount of time so basically when we looked at this studies a hole which we kind of were pushing it towards the lasik dry eye it was obvious that even within 30 days we looked at the sixty day cycle as well we had improvements in the chronic dry eye symptoms and we also had a

Decrease in the impact on the dry daily activities most patients roughly two-thirds saw relief within three weeks and a majority of the patients saw a decreased frequency of the artificial tear use it was amazing at how their daily activities of living were improved it was amazing at their reduction in amount of tear usage and the patients were reporting that you

Know this is a great thing the one issue that i found most intriguing was it wasn’t a long time for these patients to get symptomatic relief it was more like the three week to four week to five week period as as two months down the road as we thought that we were going to see with wrist aces when it was a first approved based on those fda results well we looked

Back at the fda results again and of course they were the severe drive patients which may have taken a little more time severe chronic dry eye patients are usually poor candidates for lasik dr. stonecipher nabber scribes were stasis for these patients to see if they can be converted into a healthier ocular surface so what i started initially doing in this patient

Population is using prep for teens i’m or four times a day for three days prior to surgery and if they had a significant meibomian gland dysfunction or level of blepharitis then i would add an antibiotic like docs cycling hundred milligrams twice a day to that group what we found was those patients were doing well but still at the two-week post-operative visit we

Found a lot of patients were still complaining of dry eye so we made the connection and said well let’s try over stasis twice a day in this group and let him use their artificial tears as much as they wanted to and we found out the convenience dose you know one time in the morning one time the evening was really accepted by the patient number two it actually caused

Him to decrease the amount of tears that they were using per day so then we went one step further and we looked at these severe dry patients that we may or may not have said you know you’re not really a great lasik candidate but they couldn’t wear the contact lenses anymore and they weren’t real you know fancy on wearing their glasses everywhere so what we ended

Up doing with that patient population we said well let’s put you on with stasis for a few months see how you do and we found that with a two-month venue to three-month venue of rest asis mamie’s patients were converted into a more healthy ocular surface than we’d used the bread for tina’s aimar for four times a day for three days prior to surgery and we converted

Many these patients into lasik candidates where before we wouldn’t have been able to operate on them according to doctor stonecipher some participants reported stinging upon installation of the wrist asis drops in the lasik trials we saw the 17% of the patient population reported stinging upon installation now again i like to use the analogy that you know it’s like

Putting alcohol in a wound in the severe dry eye patient and as opposed to put alcohol in the surface of your skin it’s not as severe well in this mild to moderate category we didn’t really see the burning upon installation like we did in the clinical trials but if we did see it the simple solution was they put the drop in the morning they’d wait about 10 to 15

Minutes chase that with a tear like refresh tears or refresh plus and then they go about their usual daily activities and in that evening they put another drop in if they had burning they were able to go ahead and wash their eyes out in addition we’re now seeing with our contact lens patients some of the patients they can put it in in the morning okay and put

It in the evening you know before they put their contact lenses and wait about 15 minutes put the contact lens in in the evening come home take the contact lenses out put the wrist asis in and and they’re showing that you know they’re able to wear their contact lens better some study participants initially voiced concern about the price of wrist asis cost has been

Somewhat of an issue in some of the patients but 90 percent or more of the healthcare providers have this on their formulary now and so the average copay ranges anywhere between 20 and and probably thirty five forty dollars the results of the study demonstrate that wrist aces can achieve rapid symptom relief in patients presenting with chronic dry eye wrist aces

Can benefit both lasik and non lasik patients alike and in many cases convert a severe dry eye patient into a candidate for lasik at the present time with stasis is the only therapeutic tier it’s the only actual drop that increases tear production the other ocular surface lubricants are really tear supplements and tear replacements i think that you’re seeing people

Use some of these other products in conjunction with wrist asis post lasik but i think that there were stasis like i said before somebody’s got to do something why not do something that’s going to make a therapeutic effect you

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What are the results of Restasis testing and cyclosporine of treatment of chronic dry eye disease? By Eye News TV